FDA UDI
In Commercial Distribution
🇺🇸 United States
SWAT-T Elastic Tourniquet, Black
DI: 00857048006392
·
Model: 1
·
H&H MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SWAT-T Elastic Tourniquet, Black
- Primary DI
- 00857048006392
- Version / Model
- 1
- Catalog Number
- SWAT-T-BLK-EA
- Company Name
- H&H MEDICAL CORPORATION
- Labeler DUNS
- 072656713
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-31
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 538d07f4-66bf-4ce7-94e2-11391f29c1b7
Device Description
SWAT-T Elastic Tourniquet, used to stop or slow severe hemorrhaging from injured limbs and to reduce blood loss.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58128 | Limb tourniquet, manual, single-use | A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It typically does not include latex and may be available in a variety of designs (e.g., Velcro or a self-locking buckle, synthetic rubber band). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00857048006453 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00857048006392 | GS1 |
Customer Contacts
- Phone
- 804-642-3663
- [email protected]