FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380174726
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CHB4066
Catalog number
CHB4066
Device description
Strap Tourniquet
Published
2020-11-19
Public version status
Update
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
50885380174726PackageGS120In Commercial Distribution
20885380174725PrimaryGS10
10885380174728Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538017472650885380174726
2088538017472520885380174725
1088538017472810885380174728

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff, single-useA band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. 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
961027315
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
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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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