FDA.reportPublic FDA data

Chongjen

Primary DI
06974681690307
Brand
Chongjen
Company
SHANGHAI CHONGJEN INDUSTRY CO., LTD.
Model
"Mesh Cap,18"""
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
FYFCap, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974681690307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974681690307069746816903076974681690307

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

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
06974681690314Chongjen"Mesh Cap,21"""2023-01-17
06974681690321Chongjen"Mesh Cap,24"""2023-01-17
06974681690338ChongjenIsolation Gown,S2023-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199536901131BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901148BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901155BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901162BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901179BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901186BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
10840330706671ProCureTwin Med, LLCFYF2026-05-05
20197344202215MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-03-16
20680651497271HalyardO&M HALYARD, INC.FYF2025-10-24
TQ26126151701Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126151991Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126152001Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
10810141933238VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933245VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933252VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933269VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933276VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933283VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933290VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933306VIVIT SupplyVivit Supply LLCFYF2024-11-29
10097604414033Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604419014Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604455029Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604474112Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
20197344099945MedlineMEDLINE INDUSTRIES, INC.FYF2024-04-11
20197344036483MedlineMEDLINE INDUSTRIES, INC.FYF2023-12-19
30884389102590MedlineMEDLINE INDUSTRIES, INC.FYF2023-10-13