FDA UDI
In Commercial Distribution
🇺🇸 United States
T.A.L Tactical Aid Lifesaver
DI: 07290020471000
·
Model: 01
·
SINGER INSTRUMENTS & CONTROL LTD.
Product Codes
2
GMDN Terms
2
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- T.A.L Tactical Aid Lifesaver
- Primary DI
- 07290020471000
- Version / Model
- 01
- Company Name
- SINGER INSTRUMENTS & CONTROL LTD.
- Labeler DUNS
- 600049183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-25
- Public Version
- 1
- Public Version Date
- 2025-10-03
- Public Version Status
- New
- Public Device Record Key
- dddddee6-ed40-4bf2-a603-1102c5580890
Device Description
Pneumatic and Non-pneumatic Arterial Tourniquet - Blood flow stopping system
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | 878.5910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65141 | Arterial tourniquet, pneumatic | An inflatable cuff with fastening mechanism intended to be placed around a patient's limb (arm or leg) and pneumatically inflated from an integrated small gas cartridge to reduce and/or occlude arterial blood circulation to the distal portion of the limb during an emergency situation. It is typically used by emergency medical services (EMS) for emergency blood loss prevention. This is a single-use device. | No | Active |
| 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 |
|---|---|---|---|---|---|---|
| Primary | 07290020471000 | GS1 | ||||
| Package | 17290020471007 | GS1 | Pouch | 100 | In Commercial Distribution | |
| Package | 17290020471014 | GS1 | Box | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- +972546398255
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius