FDA.reportPublic FDA data

First Aid Only

Primary DI
00092265508599
Brand
First Aid Only
Company
Acme United Corporation
Model
M5085
Catalog number
M5085
Device description
Splint Inflatable - Full arm
Published
2022-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZFSplint, Extremity, Inflatable, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZFSplint, Extremity, Inflatable, ExternalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00092265508599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00092265508599000922655085990922655085990092265508599

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable extremity splintA non-sterile sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies, e.g., accidents and motor vehicle crashes, to stabilize the limb for transport to a hospital. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-835-2263customerservice@acmeunited.com

Regulatory Flags#

DUNS number
001180207
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00092265917841First Aid Only917842026-04-23
00738743007139First Aid Only3606493606492022-01-10
00092265001472First Aid OnlyAN147AN1472021-08-10
00092265313179First Aid OnlyFAE-3131FAE-31312021-08-10
00073577900998First Aid Only90099-00290099-0022020-10-02
00092265100977First Aid Only10097100972020-10-02
00738743080309First Aid Only803080302020-12-11
00092265716086First Aid Only7116087116082020-10-06
00092265960021First Aid Only96002960022025-09-30
00092265508391First Aid OnlyM5083M50832022-01-21
00092265508490First Aid OnlyM5084M50842022-01-21
00092265508698First Aid OnlyM5086M50862022-01-21
00092265508797First Aid OnlyM5087M50872022-01-21
00092265508896First Aid OnlyM5088M50882022-01-21
00738743210119First Aid Only21-01121-0112022-12-15
00092265022040First Aid OnlyB204B2042021-07-15
00738743961424Elite First Aid96142961422025-06-12
00738743961431Elite First Aid96143961432025-06-12
00092265002066First Aid OnlyAN206AN2062021-08-11
00092265022071First Aid OnlyB207B2072021-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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24251853902854Body Armor® PFA Walker LinerDarco (Europe) GmbHFZF2025-04-15
24251853902861Body Armor® PFA Walker LinerDarco (Europe) GmbHFZF2025-04-15
04251853902874Body Armor® PFA Walker LinerDarco (Europe) GmbHFZF2025-04-15
00609271040106Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
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00609271040335Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040342Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
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00609271040373Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040380Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
00609271040397Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040100Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040117Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
20609271040124Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22
10609271040134Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.FZF2023-09-22