FDA.reportPublic FDA data

Huanfu

Primary DI
06974239590004
Brand
Huanfu
Company
Hubei Huanfu Plastic Products Co., Ltd.
Model
blue,15x41cm,CPE 3.8g/pc,hand-made
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FXPCover, Shoe, Operating-Room
KMEBedding, Disposable, Medical
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1
KMEBedding, Disposable, MedicalGeneral Hospital1
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26974239590008PrimaryGS10
26974239590060PrimaryGS10
26974239590077PrimaryGS10
06974239590004Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697423959000826974239590008
2697423959006026974239590060
2697423959007726974239590077
06974239590004069742395900046974239590004

GMDN Terms#

Term, Definition table
TermDefinition
Shoe coverA loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530032259
Device count
1000
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26974239590053HUANFUlight blue2023-01-05
26974239590060HUANFUwhite2023-01-05
26974239590077HUANFUwhite with printing2023-01-05
26974239590039HUANFUlight blue PP80g, 40x89''2022-12-31
26974239590046HUANFUlight blue2022-12-31
26974239590022HUANFUlight blue SMS43g,19x44.5cm2022-12-29
26974239590015HUANFUlight blue,41''x62''HF00302022-12-28
26974239590008Huanfublue,15x41cm,CPE 3.8g/pc,hand-made2022-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)Dynarex CorporationKME2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)Dynarex CorporationKME2026-06-08
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
00199536911109BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911147BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911154BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911161BluelineTransparent Supply Solutions Ltd.KME2026-05-15
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
20885380151511CARDINAL HEALTHCARDINAL HEALTH 200, LLCOEA2025-03-22
10097604466407Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2024-09-16
07613327632835Sage Multi-Position MATSSAGE PRODUCTS, LLCKME2024-08-12
10193489099560MEDLINEMEDLINE INDUSTRIES, INC.OEA2024-07-04
07613327632873Sage TAP LCSAGE PRODUCTS, LLCKME2024-03-26
07613327632880Sage TAP LCSAGE PRODUCTS, LLCKME2024-03-26
10097604546727Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2023-12-11
10097604546741Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2023-12-11
10197106108482CARDINAL HEALTHCardinal Health 200, LLCOEA2023-09-12
10097604459546Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-08-28
10097604469750Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-08-28
08052141310069Green gown with elastics (length 120 cm)OMNIA SRLOEA2023-06-22
08052141310083Green gown with cuffs (length 120 cm)OMNIA SRLOEA2023-06-22
08052141310120Expo model gown (length 130 cm) size M/LOMNIA SRLOEA2023-06-22
08052141310144Expo model gown (length 133 cm) size XLOMNIA SRLOEA2023-06-22
08052141310182Expo model gown (length 118 cm) size SOMNIA SRLOEA2023-06-22