FDA UDI
In Commercial Distribution
🇺🇸 United States
Hema-T
DI: 07290012685187
·
Model: Hema-T - Single Unit
·
ONEG HAKARMEL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Hema-T
- Primary DI
- 07290012685187
- Version / Model
- Hema-T - Single Unit
- Catalog Number
- SAHS-30-80-T
- Company Name
- ONEG HAKARMEL LTD
- Labeler DUNS
- 534017256
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-03
- Public Version
- 1
- Public Version Date
- 2025-02-11
- Public Version Status
- New
- Public Device Record Key
- ae0ee5b3-c15c-46a7-86ad-6a279d544417
Device Description
Arterial tourniquet, manual, single use
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | 878.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67046 | Arterial tourniquet, manual, single-use | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07290012685453 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 07290012685187 | GS1 |
Customer Contacts
- Phone
- (866) 503.1470
- [email protected]