Identity
- Trade Name
- PTS Hose Set - Single (Male Connector) FDA UDI
- Generic Name
- Surgical pneumatic tourniquet system FDA UDI
- Device Name
- PTS Hose Set (Male metal connector) for use with Personalized Tourniquet System (PTS) for Blood Flow Restriction (BFR) FDA UDI
- Model / Reference
- 9-2200-025 FDA UDI
- Description
- PTS Hose Set (Male metal connector) for use with Personalized Tourniquet System (PTS) for Blood Flow Restriction (BFR) FDA UDI
Identifiers
- Primary DI / UDI-DI
- M995922000253 FDA UDI
- FDA Product Code
- KCY FDA UDI
- GMDN Term
- Surgical pneumatic tourniquet system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.5910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical pneumatic tourniquet system
PTS Hose Set - Single (Male Connector) by Delfi Medical Innovations Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical pneumatic tourniquet system.
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- A.T.S.® Personalized Pressure® — Zimmer Orthopaedic Surgical Products · Class I
- DTS-3000 — DAESUNG MAREF CO., LTD. · Class I
- A.T.S.® Personalized Pressure® — Zimmer Orthopaedic Surgical Products · Class I
- A.T.S.® Personalized Pressure® — Zimmer Orthopaedic Surgical Products · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Delfi Medical Innovations Inc
Sources (1)
- FDA UDI 3ba4bb79-22ca-4cdd-9ed2-bb8b50d05bea 34 fields · synced May 29, 2026