Identity
- Trade Name
- PTSii Personalized Tourniquet System FDA UDI
- Generic Name
- Surgical pneumatic tourniquet system FDA UDI
- Device Name
- (Single Channel, Single Port System) The Delfi PTS ii Portable Tourniquet System is intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. FDA UDI
- Model / Reference
- 9-2200-001 FDA UDI
- Description
- (Single Channel, Single Port System) The Delfi PTS ii Portable Tourniquet System is intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M995922000011 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical pneumatic tourniquet system
PTSii Personalized Tourniquet System 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.
- DTS-3000 — DAESUNG MAREF CO., LTD. · Class I
- DTS-3000 — DAESUNG MAREF CO., LTD. · Class I
- Zimmer Tourniquet — RENU MEDICAL, INC · Class I
- LiveBand BFR — INNOVATION INSTITUTE, LLC · Class I
- 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 049cf9bf-574d-46a1-ad15-07773603b4e8 34 fields · synced Jun 8, 2026