FDA.reportPublic FDA data

ALL-HEALTH Wound Care Products

Primary DI
20017276234477
Brand
ALL-HEALTH Wound Care Products
Company
Aso LLC
Model
017276234473
Device description
Flexible Foam Adhesive Pad, all one size, dressing 3.5 IN x 4.5 IN (88 mm x 114 mm), pad size 2 IN x 3 IN (50 mm x 76 mm)
Published
2020-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20017276234477PackageGS172In Commercial Distribution
00017276234473PrimaryGS10
60017276234475Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2001727623447720017276234477
00017276234473000172762344730172762344730017276234473
6001727623447560017276234475

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-823-4545udi@asocorp.com

Regulatory Flags#

DUNS number
152793493
Device count
10
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20017276241338Bluey First Aid Kit017276241334X004ZGMMNJ2026-03-03
20017276241314CARE SCIENCE0172762413102026-02-03
20017276241284CARE SCIENCE0172762412802026-01-06
20017276240997Bluey 0172762409932025-08-29
60017276240810Bluey0172762408182025-08-13
20017276240850Bluey01727624085663610832025-08-13
20017276240805THE GRINCH0172762408012025-08-12
00017276240863THE GRINCH01727624086363610912025-08-12
10017276237679CarePak0172762376722021-05-28
20017276240829minions0172762408252025-05-06
20017276240799THE CAT IN THE HAT0172762407952025-04-23
00017276240689Carepak value pack017276240689X004L9FIJZ2025-04-10
20017276240720minions017276240726X004LQRJI12025-04-09
20017276240331CARE SCIENCE0172762403372025-03-20
20017276240348CARE SCIENCE0172762403442025-03-20
20000172762397Bluey 017276239300X004JE7MZP2023-01-31
20017276240492Sparkle & Shine Antibacterial Bandages017276240498X004JE7MZP2025-02-19
20017276240188Crayola First Aid Kit017276240054X004GS4AXB2025-02-10
60017276240452Sesame Street0172762404502025-02-10
60017276240469Bluey 0172762404672025-02-10

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