Identity
- Trade Name
- SAM® Junctional Tourniquet FDA UDI
- Generic Name
- Emergency junctional haemorrhage compression set FDA UDI
- Device Name
- SAM Junctional Tourniquet Trainer - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Hand Pump & Bag FDA UDI
- Model / Reference
- JT402-EN FDA UDI
- Description
- SAM Junctional Tourniquet Trainer - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Hand Pump & Bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822045000346 FDA UDI
- 510(k) Number
- K131561 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Emergency junctional haemorrhage compression set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Emergency junctional haemorrhage compression set
SAM® Junctional Tourniquet by SAM Medical Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Emergency junctional haemorrhage compression set.
- JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT®) — NORTH AMERICAN RESCUE, LLC. · Class II
- CrOC — SAFEGUARD US OPERATING, LLC · Class II
- FORWARD AAJT-S Deployment Kit — INTEGRATED MEDCRAFT LLC · Class II
- SAM® Junctional Tourniquet — SAM Medical Products · Class II
Cleared under the same submission
K131561 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SAM Medical Products
Sources (1)
- FDA UDI 08b5b65b-33aa-4cec-96c7-9cc60a144d22 35 fields · synced Jun 8, 2026