FDA.reportPublic FDA data

HemaShock

Primary DI
07290012685156
Brand
HemaShock
Company
ONEG HAKARMEL LTD
Model
HemaShock EMS - Single Unit
Catalog number
SAHS-EM-SN-01A
Device description
Arterial tourniquet, manual, single use
Published
2025-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
07290012685156PackageGS15In Commercial Distribution
07290012685439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290012685156072900126851567290012685156
07290012685439072900126854397290012685439

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.

Sterilization Methods#

Method table
Method

Contacts#

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

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
07290012685477HemaClearHemaClear XL (double sleeve)PRH090BW02A2025-09-29
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
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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