FDA.reportPublic FDA data

Tape and bandage, adhesive, adjustable closing mechanism, OTC use

Primary DI
06971257033780
Brand
Tape and bandage, adhesive, adjustable closing mechanism, OTC use
Company
Weihai Kangzheng Medical Equipment Technology Co., Ltd
Model
TB-4
Device description
Used to provide binding force on wound dressings or limbs for binding and fixation purposes.
Published
2024-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc UseGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971257033780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971257033780069712570337806971257033780

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, non-siliconeA long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554480344
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971257033698Tape and bandage, adhesive, adjustable closing mechanism, OTC useTB-22024-06-22
06971257033704Tape and bandage, adhesive, adjustable closing mechanism, OTC use TB-32024-06-22
06971257033773Tape and bandage, adhesive, adjustable closing mechanism, OTC useTB-12024-06-22
06971257033797Tape and bandage, adhesive, adjustable closing mechanism, OTC use TB-52024-06-22
06971257033803Tape and bandage, adhesive, adjustable closing mechanism, OTC use TB-62024-06-22
06971257033810Tape and bandage, adhesive, adjustable closing mechanism, OTC use TB-72024-06-22
06971257033827Tape and bandage, adhesive, adjustable closing mechanism, OTC use TB-82024-06-22
06971257033834Tape and bandage, adhesive, adjustable closing mechanism, OTC use TB-92024-06-22
06971257033841Tape and bandage, adhesive, adjustable closing mechanism, OTC use TB-102024-06-22
06971257037177urinalysis strips3T2024-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971257033698Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033704Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033773Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033797Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033803Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033810Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033827Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033834Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033841Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
00840118608978ENDURE INDUSTRIESENDURE INDUSTRIESPYO2024-03-26
00840118602273ENDURE INDUSTRIESENDURE INDUSTRIESPYO2024-03-26
00853909006518DermaQuikDermaclip Us, L.L.C.PYO2023-04-20
00853909006525DermaQuikDermaclip Us, L.L.C.PYO2023-04-20
00350770003757ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003764ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003771ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003788ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003795ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003754ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003761ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003778ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003785ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003792ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00842071131036CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2022-03-30
00842071131043CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2022-03-30
00860001701098PharmChem, Inc. Transparent Overlay Film with CutoutPHARMCHEM, INC.PYO2021-08-26
00860002279626PharmChem, Inc. Transparent Overlay Film with CutoutPHARMCHEM, INC.PYO2021-08-26
00842071130930CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2020-11-04
00842071130947CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2020-11-04
00842071130954CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2020-11-04