FDA.reportPublic FDA data

Chongjen

Primary DI
06974681690437
Brand
Chongjen
Company
SHANGHAI CHONGJEN INDUSTRY CO., LTD.
Model
Coverall,XL
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
FXOSuit, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXOSuit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974681690437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974681690437069746816904376974681690437

GMDN Terms#

Term, Definition table
TermDefinition
Visitor hygiene coverallA garment intended to be worn by a visitor, or staff, in a healthcare facility as temporary clean clothing when with patients in non-sterile environments that may require a higher level of hygiene than a normal patient ward [e.g., intensive care unit (ICU), postoperative recovery ward]. Also known as a jump suit, it is a one-piece suit (overall) with sleeves, trouser legs, and fasteners intended to be worn over existing clothing to provide a barrier to help prevent cross-contamination of infectious agents between visitor and patients. 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
10097604599921Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2025-09-10
00889813060179Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
00889813060186Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
00889813060193Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060176Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060183Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060190Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
06921340881118customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340882115customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340883112customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340884119customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340885116customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340881115customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340882112customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340883119customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340884116customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340885113customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06973635612013MaoshengXianTao Maosheng Plastic Products Co., LtdFXO2023-03-31
10850044799593SURGYCOSurgyco LLCFXO2023-02-16
10850044799609SURGYCOSurgyco LLCFXO2023-02-16
10850044799616SURGYCOSurgyco LLCFXO2023-02-16
10850044799623SURGYCOSurgyco LLCFXO2023-02-16
10850044799630SURGYCOSurgyco LLCFXO2023-02-16
10850044799647SURGYCOSurgyco LLCFXO2023-02-16
10850044799654SURGYCOSurgyco LLCFXO2023-02-16
10850044799661SURGYCOSurgyco LLCFXO2023-02-16
10850044799678SURGYCOSurgyco LLCFXO2023-02-16
10850044799685SURGYCOSurgyco LLCFXO2023-02-16
00850044799596SURGYCOSurgyco LLCFXO2023-02-16
00850044799602SURGYCOSurgyco LLCFXO2023-02-16