FDA.reportPublic FDA data

HemaClear

Primary DI
07290012685477
Brand
HemaClear
Company
ONEG HAKARMEL LTD
Model
HemaClear XL (double sleeve)
Catalog number
PRH090BW02A
Device description
HemaClear XL (double sleeve) - single unit
Published
2025-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
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
07290012685477PackageGS110In Commercial Distribution
07290012685460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290012685477072900126854777290012685477
07290012685460072900126854607290012685460

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
534017256
Device count
1
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
true
Expiration date on label
true
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
07290012685460HemaClearHemaClear XL (double sleeve)PRH090BG02A2025-09-29
07290012685484HemaClearHemaClear Long PinkPRH028PI02A2025-09-29
07290012685491HemaClearHemaClear Long PinkPRH028PI02A2025-09-29
07290012685187Hema-THema-T - Single UnitSAHS-30-80-T2025-02-03
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
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30197344006230MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
00087453143478HysynalHYGENIC CORPORATION, THEGAX2025-03-10
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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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