FDA.reportPublic FDA data

Chongjen

Primary DI
06974681690512
Brand
Chongjen
Company
SHANGHAI CHONGJEN INDUSTRY CO., LTD.
Model
Lab Coat,XXL
Published
2023-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974681690512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974681690512069746816905126974681690512

GMDN Terms#

Term, Definition table
TermDefinition
Assistive coatAn over garment (e.g., an overcoat or jacket) specially designed/adapted to be worn by a person with a disability for outdoor use. It may be worn by a male or a female and is typically constructed with features to facilitate easy donning, fastening, and removal (e.g., wide sleeves, large pockets, Velcro or zip fasteners).

Regulatory Flags#

DUNS number
560012294
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974681690604ChongjenCPE Gloves,S2023-01-19
06974681690611ChongjenCPE Gloves,M2023-01-19
06974681690628ChongjenCPE Gloves,L2023-01-19
06974681690635ChongjenCPE Gloves,XL2023-01-19
06974681690475ChongjenLab Coat,S2023-01-18
06974681690482ChongjenLab Coat,M2023-01-18
06974681690499ChongjenLab Coat,L2023-01-18
06974681690505ChongjenLab Coat,XL2023-01-18
06974681690529ChongjenLab Coat.XXXL2023-01-18
06974681690536ChongjenLab Coat,XXXXL2023-01-18
06974681690550ChongjenLDPE Gloves,M2023-01-18
06974681690567ChongjenLDPE Gloves,L2023-01-18
06974681690574ChongjenHDPE Gloves,M2023-01-18
06974681690581ChongjenHDPE Gloves,L2023-01-18
06974681690598ChongjenHDPE Gloves,XL2023-01-18
06974681690291Chongjen"Bouffant Cap,24"""2023-01-17
06974681690307Chongjen"Mesh Cap,18"""2023-01-17
06974681690314Chongjen"Mesh Cap,21"""2023-01-17
06974681690321Chongjen"Mesh Cap,24"""2023-01-17
06974681690338ChongjenIsolation Gown,S2023-01-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40884389804637MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
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40080196772026MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-03
00199536901001BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901018BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901308BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901315BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901407BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901414BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901421BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901438BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901445BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901452BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901469BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901476BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00842942017506PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
00842942017513PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
00842942016530PRIMEDpriMED Medical Products IncOEA2025-07-21
00842942015700PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942015717PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017261PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017278PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942007934PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942008047PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942009570PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942009587PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942014406PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942014420PRIMEDpriMED Medical Products IncOEA2025-07-15