FDA.reportPublic FDA data

First Aid Only

Primary DI
00738743170116
Brand
First Aid Only
Company
Acme United Corporation
Model
17-011
Catalog number
17-011
Device description
1" X 18" Tourniquet, 1 per Box
Published
2021-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00738743170116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00738743170116007387431701167387431701160738743170116

GMDN Terms#

Term, Definition table
TermDefinition
Arm/leg tourniquet, single-useA strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It typically does not include latex and may be available in a variety of designs (e.g., Velcro or a self-locking buckle, synthetic rubber band). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00738743210119First Aid Only21-01121-0112022-12-15
00738743961424Elite First Aid96142961422025-06-12
00738743961431Elite First Aid96143961432025-06-12
00738743007030First Aid OnlyM284-400M284-4002023-01-06
00092265912617First Aid Only91261912612023-07-21
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10810132043427HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043434HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043441HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043458HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043465HCSConcordance Healthcare Solutions LLCGAX2025-12-05
00850063404396easycareSynchronis Medical, LLCGAX2025-12-05
00842209136636NARNORTH AMERICAN RESCUE, LLCGAX2025-11-24
00842209136643NARNORTH AMERICAN RESCUE, LLCGAX2025-11-24
07290012685477HemaClearONEG HAKARMEL LTDGAX2025-09-29
07290012685491HemaClearONEG HAKARMEL LTDGAX2025-09-29
07290020471000T.A.L Tactical Aid Lifesaver SINGER INSTRUMENTS & CONTROL LTD.GAX2025-09-25
00860003436424Multi-TENTROTECH LIFE SCIENCES, LLCGAX2025-06-30
00860003436455Multi-TENTROTECH LIFE SCIENCES, LLCGAX2025-06-30
00869193000040T-RING FLEX Digit TourniquetPRECISION MEDICAL DEVICES, LLCGAX2025-06-11
10869193000016T-RING Digit TourniquetPRECISION MEDICAL DEVICES, LLCGAX2025-06-10
08057592700025TOURNIK-ITFLAMOR SRLGAX2025-05-28
08057592700032TOURNIK-ITFLAMOR SRLGAX2025-05-28
08057592700049TOURNIK-ITFLAMOR SRLGAX2025-05-28
10661392011677LSL HEALTHCARELSL Industries, LLCGAX2025-05-16
10661392011691LSL HEALTHCARELSL Industries, LLCGAX2025-05-16
10661392053585LSL HEALTHCARELSL Industries, LLCGAX2025-05-16
30665973032390DukalDukal LLCGAX2025-04-08
30665973032406DukalDukal LLCGAX2025-04-08
00840490800007PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
10840490800011PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
10840490800028PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
10840490800035PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
00840490800045PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04