FDA.reportPublic FDA data

Chongjen

Primary DI
06974681690338
Brand
Chongjen
Company
SHANGHAI CHONGJEN INDUSTRY CO., LTD.
Model
Isolation Gown,S
Published
2023-01-17
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
06974681690338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974681690338069746816903386974681690338

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

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
06974681690512ChongjenLab Coat,XXL2023-01-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118617567Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617581Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617604Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617628Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617659ENDURE INDUSTRIESENDURE INDUSTRIESOEA2026-08-03
00840118617673Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617697Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617710Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617741Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617772Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617802Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118687690Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118698399Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
30193489103964MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489103971MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489104893MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489107969MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120241MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120258MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50080196247576MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50193489109885MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50193489109892MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40884389804637MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
50193489108239MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
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