FDA.reportPublic FDA data

Compeed Blister Sport Pack 5p USA

Primary DI
00810000310029
Brand
Compeed Blister Sport Pack 5p USA
Company
HRA PHARMA AMERICA, INC.
Model
00810000310029
Device description
Blister Support Bandage Cushion
Published
2020-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810000310029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810000310029008100003100298100003100290810000310029

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(862)260-9988xxx@xx.xx

Regulatory Flags#

DUNS number
081160441
Device count
1
Premarket exempt
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810000310265Mederma Medical Grade Silicone Scar Sheet Large 4ct008100003102652022-08-08
00810000310258Mederma Medical Grade Silicone Scar Sheet Small 4ct008100003102582022-02-05
00810000318018Compeed Advanced Blister Care Medium 12p008100003180182020-11-17
00810000318025Compeed Advanced Blister Care Sports Mixed 9p (6+3)008100003180252020-11-17
00810000318292Compeed Advanced Blister Care Medium Skin Tone x10008100003182922021-04-20
00810000310371Compeed Advanced Blister Care Mixed 6008100003103712023-02-15
00810000318162Mederma Cold Sore 15ct8100003181622020-10-02
00810000310012Compeed Blister Medium 5p USA008100003100122020-07-04
00810000310036Compeed Blister Mix Pack 5p USA008100003100362020-07-04
00810000310043Compeed Blister Small 6p USA008100003100432020-07-04
00810000310050Compeed Corn Medium 10p USA008100003100502020-07-04
00810000310067Compeed Twin Pack Blister Medium 2x5ct008100003100672020-07-04
00810000310074Compeed Twin Pack Blister Extreme 5p USA008100003100742020-07-04
00810000310081Compeed Twin Pack Blister Mix Pack 2+2+1p USA008100003100812020-07-04
00810000310098Compeed Twin Pack Blister Sml 6p USA008100003100982020-07-04
00810000310104Compeed Twin Pack Corn Med 10p USA008100003101042020-07-04
00810000310111Compeed Twin Pack Blister Sports Medium 8ct008100003101112020-07-04
00810000310128Compeed Twin Pack Blister Sports Mixed 9ct008100003101282020-07-04
00810000310135Compeed Twin Pack Blister High Heel 9ct008100003101352020-07-04
00810000310166Compeed Advanced Blister Care Medium 1p008100003101662020-07-04

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