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SAM® Junctional Tourniquet
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref JT401-EN510(k) K123694
Identity
- Trade Name
- SAM® Junctional Tourniquet EUDAMEDFDA UDI
- Generic Name
- Emergency junctional haemorrhage compression set FDA UDI
- Device Name
- SAM® Junctional Tourniquet EUDAMEDSAM Junctional Tourniquet - SJT Belt with TCD, Hand Pump & Bag FDA UDI
- Model / Reference
- JT401-EN EUDAMEDFDA UDI
- Description
- SAM Junctional Tourniquet - SJT Belt with TCD, Hand Pump & Bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822045000360 EUDAMEDFDA UDI
- Basic UDI-DI
- 0822045JT01TF EUDAMED
- 510(k) Number
- K131561 FDA UDI
- FDA Product Code
- DXC FDA UDI
- EMDN Code
- V9003 TOURNIQUETS EUDAMED
- GMDN Term
- Emergency junctional haemorrhage compression set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
SAM® Junctional Tourniquet by SAM Medical Products — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131561 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K123694 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0822045JT01TF | Class I | Active |
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Manufacturer
- Manufacturer
- SAM Medical Products
- EUDAMED SRN
- US-MF-000002589
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 9efe9a94-5542-41f2-8dc4-12d6e168db73 85 fields · synced Jun 18, 2026
- FDA UDI 045bef91-4c84-49ca-b638-f9331c030fca 35 fields · synced May 29, 2026
- FDA 510(k) K131561 1 fields · synced May 18, 2026