@repo/shared / CometicMedicalRadiationType
Interface: CometicMedicalRadiationType
FDA Cosmetics, Medical Devices, and Radiation-Emitting Products PGA data for CBP entry summary filings.
Covers three FDA commodity programs: COS (Cosmetics), DEV (Medical Devices), and RAD
(Radiation-Emitting Products), all regulated by FDA's Center for Devices and Radiological Health
(CDRH). Select the applicable program via govAgencyProgramCode.
Properties
| Property | Type | Description |
|---|---|---|
affirmations? | {code?: string;qualifier?: string;}[] | Array of affirmation of compliance records. Each affirmation has a code and an optional qualifier value. Repeatable, but each code can only appear once per PGA line. COS: COS (registration number, optional) and ERR (indicator only, optional). (Table 6-15/6-16) DEV: Many codes including PM#, DDM, DEV, DFE, DI, CPT, IFE, ERR, IDE, IRC, KIT, etc. (Tables 11-16 to 11-21) RAD: R87, RCL, RAS, INS, ERR, etc. (Tables 13-17 to 13-19) Per CATAIR FDA 08-25.pdf: Optional/Conditional record, repeatable per PGA line. |
arrivalDate? | Date | Anticipated arrival date at port of entry. Per CATAIR FDA 08-25.pdf, Tables 6-21, 11-28, 13-26: positions 6-13, MMDDCCYY, Mandatory if status='A'. |
arrivalLocation? | string | FIRMS code or port of arrival location. For entry type 21: FIRMS code is required (location code = "4"). For other entry types: left blank or Schedule D port code. Per CATAIR FDA 08-25.pdf, Tables 6-21, 11-28, 13-26: positions 22-71, 50X, Conditional (C). |
arrivalTime? | string | Anticipated arrival time at port of entry in military time (HHMM). For midnight, use 2400 (0000 is invalid). Per CATAIR FDA 08-25.pdf, Tables 6-21, 11-28, 13-26: positions 14-17, 4N, Mandatory if status='A'. |
brandName? | string | Trade or brand name of the product. COS: Optional (Table 6-8). DEV/NED: Optional, encouraged if available (Table 11-8). DEV/RED: Conditional — mandatory if product requires Form 2877 (Table 11-8). RAD: Conditional — mandatory if product requires Form 2877 (Table 13-9). Per CATAIR FDA 08-25.pdf: positions 5-39, up to 35 chars. Continue in PG60 with "TBN" if needed. |
containers? | {containerNumber?: string;}[] | Array of shipping container numbers. Each element holds one container number. The encoder packs three consecutive elements into a single PG27 CATAIR record (positions 5-24, 28-47, 51-70). Up to 20 alphanumeric chars per number. Per CATAIR FDA 08-25.pdf, Tables 6-20, 11-27, 13-25: Optional, repeatable per PGA line. |
correctionIndicator? | boolean | Indicator for filing a correction to a previously submitted PGA Message Set. Per CATAIR FDA 08-25.pdf, Tables 6-3, 11-3, 13-3: position 79, Optional (O) / for future use. |
deliveredToEntity? | EntityReference | Delivered-To Party (role code: DP). Mandatory for COS, DEV, and RAD per Tables 6-10, 11-11, 13-12. PG19 Entity Name + Address 1 mandatory; PG20 City + Country mandatory. State/Province and Postal Code required for US/Canadian entities. |
disclaimer? | "A" | "F" | Disclaimer code declaring that a full PGA Message Set is not being provided. A = Product is not regulated by this agency. F = Product manufactured in US/DC/PR and never left (Entry Type 21 only). Per CATAIR FDA 08-25.pdf, Tables 6-3, 11-3, 13-3: position 80, Conditional (C). |
fdaImporterEntity? | EntityReference | FDA Importer of Record (role code: FD1). Mandatory for COS, DEV, and RAD per Tables 6-10, 11-11, 13-12. PG19 Entity Name + Address 1 mandatory; PG20 City + Country mandatory. State/Province and Postal Code required for US/Canadian entities. PG21 is also mandatory: at least one individual contact with name, phone, and email. |
govAgencyProcessingCode? | "RED" | "NED" | "REP" | Government Agency Processing Code further categorizing the product within the program. Only applicable for DEV and RAD: DEV: RED (Radiation Emitting Devices) or NED (Non-Radiation Emitting Devices) per Table 11-3. RAD: REP (Non-Medical Radiation Emitting Products) per Table 13-3. COS: No processing code applies per Table 6-3. Per CATAIR FDA 08-25.pdf: positions 14-16, Conditional (C). |
govAgencyProgramCode? | "COS" | "DEV" | "RAD" | Government Agency Program Code identifying which FDA commodity program applies. COS = Cosmetics (Table 6-1) DEV = Medical Devices (Table 11-1) RAD = Radiation Emitting Products (Table 13-1) Per CATAIR FDA 08-25.pdf, Tables 6-3, 11-3, 13-3: positions 11-13, Conditional (C). Mandatory when not disclaiming. |
intendedUseCode? | | "081.001" | "081.002" | "081.003" | "081.004" | "081.005" | "081.006" | "081.007" | "081.008" | "085.000" | "090.000" | "100.000" | "110.000" | "120.000" | "130.000" | "140.000" | "150.000" | "155.000" | "155.009" | "180.000" | "180.014" | "180.015" | "920.000" | "920.001" | "920.002" | "940.000" | "950.001" | "950.002" | "970.000" | "970.001" | "980.000" | Code identifying the intended use for the commodity after importation. Each program has its own valid set of intended use codes: COS: Table 6-4 (optional per Table 6-3) DEV: Table 11-4 (conditional per Table 11-3 — mandatory when not disclaiming) RAD: Table 13-4 (conditional per Table 13-3 — mandatory when not disclaiming) Per CATAIR FDA 08-25.pdf: positions 42-57, Conditional (C). |
lotNumbers? | {lotNumber?: string;}[] | Manufacturer-assigned lot numbers for the product. Repeatable — each element generates one PG25 record. Per CATAIR FDA 08-25.pdf, Tables 6-18, 11-23, 13-21: positions 16-40, 25 chars, Optional (O). |
manufacturerEntity? | EntityReference | Manufacturer of goods (role code: MF). Mandatory for COS, DEV, and RAD per Tables 6-10, 11-11, 13-12. PG19 Entity Name + Address 1 mandatory; PG20 City + Country mandatory. State/Province and Postal Code required for US/Canadian entities. |
packaging? | {quantity?: number;unitOfMeasure?: | "CA" | "CO" | "CT" | "FL" | "IN" | "MS" | "MT" | "NE" | "PA" | "SC" | "SD" | "TN" | "VA" | "VI" | "M" | "CR" | "EN" | "AU" | "BH" | "CL" | "L" | "MX" | "G" | "ST" | "LG" | "CS" | "SE" | "BY" | "SH" | "DR" | "PK" | "CE" | "CZ" | "CB" | "DP" | "RD" | "CAR" | "BN" | "TO" | "PCS" | "PN" | "PC" | "CI" | "BB" | "PL" | "AE" | "AM" | "AT" | "BA" | "BD" | "BE" | "BF" | "BG" | "BI" | "BJ" | "BO" | "BR" | "BS" | "BT" | "BU" | "BV" | "BZ" | "CC" | "CF" | "CG" | "CH" | "CK" | "CM" | "CU" | "CV" | "CX" | "CY" | "DJ" | "FI" | "FO" | "FR" | "GB" | "GI" | "GR" | "GZ" | "HR" | "KG" | "KM" | "LB" | "MC" | "MG" | "ML" | "NO" | "PG" | "PH" | "PT" | "PY" | "RO" | "SA" | "SK" | "SL" | "SM" | "SY" | "SZ" | "TC" | "TD" | "TK" | "TR" | "TZ" | "VG" | "AP" | "BBL" | "FP" | "FT" | "PI" | "GAL" | "CAP" | "CP" | "SW" | "CM3" | "M2" | "M3" | "AMU" | "BL" | "BQT" | "BX" | "PKG" | "PO" | "PTU" | "SAD" | "SLF" | "STM" | "TWR" | "T" | "BC" | "BK" | "BP" | "BQ" | "CAG" | "CJ" | "CON" | "CTR" | "FC" | "FD" | "HG" | "ING" | "IZ" | "JC" | "JG" | "JR" | "JT" | "JY" | "KEG" | "KIT" | "LZ" | "MB" | "NS" | "NT" | "PAL" | "PU" | "PZ" | "RG" | "RL" | "RT" | "RZ" | "SU" | "TB" | "TS" | "TU" | "TY" | "VL" | "VO" | "VP" | "VQ" | "VR" | "VY" | "WB" | "BAU" | "BOL" | "CFT" | "CYD" | "DOZ" | "DPC" | "DPR" | "FOZ" | "KM2" | "KM3" | "LNM" | "MCG" | "OZ" | "PNU" | "PRS" | "PTL" | "QTL" | "SFT" | "SQI" | "STN" | "SUP" | "SYD" | "TAB" | "TON" | "TOZ" | "YD";}[] | Array of product packaging records. Up to 6 levels allowed (outermost=1, innermost=6). Each level describes the packaging at that tier. The last level must be a base unit. The packaging qualifier (1–6) is assigned automatically by the encoder. COS: Optional (Table 6-19). DEV/NED: Optional, but quantity is conditional for DEV/RED (Table 11-24). RAD: Conditional — required if product is subject to Form 2877 (Table 13-22). Per CATAIR FDA 08-25.pdf: Repeatable up to 6 times per PGA line. |
pointOfContactEntity? | EntityReference | Point of Contact / Filer/Broker (role code: PK). Optional for COS, DEV, and RAD per Tables 6-11, 11-12, 13-13. PG19 Entity Name + Address 1 mandatory if provided; PG20 City + Country mandatory if provided. State/Province and Postal Code required for US/Canadian entities. |
productCodeNumber? | string | FDA Product Code identifying the specific product being imported. Must be exactly 7 characters in the format: Industry Code (2N) + Class Code (1AN) + Subclass Code (1A or '-') + PIC (1A or '-') + Product (2AN). Per CATAIR FDA 08-25.pdf, Tables 6-5/6-6, 11-5/11-6, 13-5/13-6: positions 10-28. |
productDescription? | string | Common, market, or usual name; free-form invoice description of the product. Not the product code description. For example, "Lipstick" or "Digital X-Ray System". Per CATAIR FDA 08-25.pdf, Tables 6-9, 11-9, 13-10: positions 24-80, 57 chars, Mandatory (M). |
remarksText? | string | Free-form text relevant to the shipment or commodity. Per CATAIR FDA 08-25.pdf, Tables 6-17, 11-22, 13-20: positions 13-80, 68 chars, Optional (O). PG24 cannot be repeated; only one PG24 per FDA line. |
shipperEntity? | EntityReference | Shipper (role code: DEQ). Mandatory for COS, DEV, and RAD per Tables 6-10, 11-11, 13-12. PG19 Entity Name + Address 1 mandatory; PG20 City + Country mandatory. State/Province and Postal Code required for US/Canadian entities. |
sources? | {countryCode?: string;sourceTypeCode?: "30" | "39" | "294";}[] | Array of source/origin records identifying the country role for this product. COS: 39 (Country of Production) mandatory; 294 (Country of Refusal) optional. (Table 6-6) DEV: 30 (Country of Source) for component or 39 (Country of Production) for finished; 294 optional. (Table 11-7) RAD: Same as DEV. (Table 13-8) Per CATAIR FDA 08-25.pdf: Mandatory record, repeatable per PGA line. |
temperatureQualifier? | "A" | "D" | "R" | "P" | "F" | "H" | "U" | Temperature category for quality control or preservation purposes. Values: A=Ambient, F=Frozen, D=Dry Ice, R=Refrigerated/Chilled, H=Fresh, U=Uncontrolled, P=Flashpoint. Per CATAIR FDA 08-25.pdf, Tables 6-18, 11-23, 13-21: position 5, Optional (O). |