FDA.reportPublic FDA data

Hema-T

Primary DI
07290012685187
Brand
Hema-T
Company
ONEG HAKARMEL LTD
Model
Hema-T - Single Unit
Catalog number
SAHS-30-80-T
Device description
Arterial tourniquet, manual, single use
Published
2025-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true
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
07290012685453PackageGS110In Commercial Distribution
07290012685187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290012685453072900126854537290012685453
07290012685187072900126851877290012685187

GMDN Terms#

Term, Definition table
TermDefinition
Arterial tourniquet, manual, single-useA device in the form of a band or strap intended to be wrapped and manually tightened around a patient's limb (arm or leg) to control/stop life-threatening (emergency) bleeding from an artery (e.g., in a military setting and/or high-risk work environment). It typically includes an adherent layer (e.g., Velcro) and/or a buckle mechanism for fastening/locking that allows adjustments to the degree of tightness. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(866) 503.1470info@hemaclear.com

Regulatory Flags#

DUNS number
534017256
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290012685460HemaClearHemaClear XL (double sleeve)PRH090BG02A2025-09-29
07290012685484HemaClearHemaClear Long PinkPRH028PI02A2025-09-29
07290012685477HemaClearHemaClear XL (double sleeve)PRH090BW02A2025-09-29
07290012685491HemaClearHemaClear Long PinkPRH028PI02A2025-09-29
07290012685415HemaClearHemaClear XXL - Single unitSAH-099-TU-01A2025-02-03
07290012685439HemaShockHemaShock EMS - Single UnitSAHS-EM-SN-01A2025-02-03
07290012685446HemaShockHemaShock Upper Extremity - Single unitPRHS-UE-SN-01A2025-02-03
07290012685453Hema-THema-T - Single UnitSAHS-30-80-T2025-02-03
07290012685422HemaClearHemaClear XXL - Single unitSAH-099-TU-01A2025-02-03
07290012685156HemaShockHemaShock EMS - Single UnitSAHS-EM-SN-01A2025-02-03
07290012685163HemaShockHemaShock Upper Extremity - Single unitPRHS-UE-SN-01A2025-02-03
07290012685217HemaClearPink Sterile Single UnitSAH028-PI-01A2024-08-24
07290012685224HemaClearGreen Sterile Single UnitSAH040-GR-01A2024-08-24
07290012685231HemaClearRed Sterile Single UnitSAH040-RE-01A2024-08-24
07290012685248HemaClearYellow Sterile Single UnitSAH040-YE-01A2024-08-24
07290012685255HemaClearBlue Sterile Single UnitSAH060-BL-01A2024-08-24
07290012685262HemaClearBrown Sterile Single UnitSAH060-BR-01A2024-08-24
07290012685279HemaClearOrange Sterile Single UnitSAH060-OR-01A2024-08-24
07290012685286HemaClearBlack Sterile Single UnitSAH-090-BW-01A2024-08-24
07290012685293HemaClearModel A (F&A) Sterile Single UnitSAH-032-MA-01A2024-08-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20197344105363MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
30197344006230MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
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30382903671985BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
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