FDA.report

First Aid Only

Primary DI
00092265050128
Brand
First Aid Only
Company
Acme United Corporation
Model
FAE-5012
Catalog number
FAE-5012
Device description
Trauma Pad, 5" x 9" - 1/bag
Published
2021-08-13
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

Related Records

Contact Domains

Product Codes

CodeName
MHWDressing, Compression

Product Code Classifications

CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00092265050128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00092265050128000922650501280922650501280092265050128

GMDN Terms

TermDefinition
Non-woven gauze pad, sterileA non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
800-835-2263xxx@xx.xx

Regulatory Flags

DUNS number
001180207
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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00738743210119First Aid Only21-01121-0112022-12-15
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00738743961431Elite First Aid96143961432025-06-12
00738743007030First Aid OnlyM284-400M284-4002023-01-06
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00092265913898First Aid Only91389913892022-09-09
00092265913904First Aid Only91390913902022-09-09
00092265913911First Aid Only91391913912022-09-09
00092265913928First Aid Only91392913922022-09-09
00092265913935First Aid Only91393913932022-09-09
00092265913980First Aid Only91398913982022-09-09
00092265914024First Aid Only91402914022022-09-09
00092265914031First Aid Only91403914032022-09-09
00092265914048First Aid Only91404914042022-09-09
00092265914055First Aid Only91405914052022-09-09
00738743002608First Aid Only36693CV36693CV2022-09-09
00738743002721First Aid Only5011715011712022-09-09
00738743006507First Aid OnlyDX0401MDX0401M2022-09-09
00092265913256First Aid Only91325913252022-08-26
00092265913263First Aid Only91326913262022-08-26

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