FDA.reportPublic FDA data

Aero-Med

Primary DI
50192253051702
Brand
Aero-Med
Company
Aero-Med, Ltd.
Model
CA27600A
Catalog number
CA27600A
Device description
Tourniquet Convenience Specimen Kit, IU Health Only
Published
2021-05-21
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

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
50192253051702PackageGS140In Commercial Distribution
20192253051701PrimaryGS10
10192253051704Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225305170250192253051702
2019225305170120192253051701
1019225305170410192253051704

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff bandage, non-latexA sterile strip or roll of non-latex containing material that is applied around an extremity (arm or leg) before the fitting of a tourniquet cuff on top of it. This device is used to protect the patient's skin from wrinkling, pinching or shearing and to protect the tourniquet cuff from becoming soiled with blood and other fluids from the operative site. It would typically be folded back over the exposed edges of the cuff to provide maximum protection. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194550042
Device count
25
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
true
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
50192253068748Aero-MedCA38075BCA38075B2025-05-01
50885380208308Aero-MedCA1500ACA1500A2025-04-18
50885380183667Aero-MedCA18750ACA18750A2025-04-15
50885380207721Aero-MedCA18725BCA18725B2025-04-15
50810010894729Aero-MedQUE3325QUE33252025-04-10
50885380207707Aero-MedCA38075BCA38075B2025-04-08
50885380207714Aero-MedCA38100BCA38100B2025-04-08
50885380208063Aero-MedCA14800BCA14800B2025-04-07
50885380198715Aero-MedCA54550CA545502024-01-08
50885380207745Aero-MedCA61875CA618752025-04-02
50885380198708Aero-MedCA32250BCA32250B2024-01-08
50885380207455Aero-MedCA61175CA611752025-03-20
50885380207677Aero-MedCA61900CA619002025-03-19
50810010894774Aero-MedAMM19300AMM193002025-03-06
50885380207363Aero-MedCA59025CA590252025-03-03
50885380207448Aero-MedCA59000CA590002025-03-03
50810010894736Aero-MedAMM18850AMM188502025-02-11
50810010894743Aero-MedAMM18875AMM188752025-02-11
50885380205536Aero-MedCA60225CA602252024-10-07
50885380206823Aero-MedCA60675CA606752025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10842942010894PRIMEDpriMED Medical Products IncGAX2026-03-03
10810132043410HCSConcordance Healthcare Solutions LLCGAX2025-12-05
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