Identity
- Trade Name
- PTS Portable Calibration System FDA UDI
- Generic Name
- Surgical pneumatic tourniquet system FDA UDI
- Device Name
- The Delfi PTS Portable Calibration System is a battery-powered pressure source pneumatically connected to a pressure regulator, calibrated pressure gauge, and pneumatic port. The regulator can be adjusted to allow the pressure source to deliver up to 750 mmHg of pressure through the pneumatic port to PTS instruments using the included pneumatic hoses. A power adaptor is included to recharge the battery and the Portable Calibration System is housed inside a rugged carrying case that can be closed for easy and safe transport. FDA UDI
- Model / Reference
- 9-2200-650 FDA UDI
- Description
- The Delfi PTS Portable Calibration System is a battery-powered pressure source pneumatically connected to a pressure regulator, calibrated pressure gauge, and pneumatic port. The regulator can be adjusted to allow the pressure source to deliver up to 750 mmHg of pressure through the pneumatic port to PTS instruments using the included pneumatic hoses. A power adaptor is included to recharge the battery and the Portable Calibration System is housed inside a rugged carrying case that can be closed for easy and safe transport. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M995922006501 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical pneumatic tourniquet system
PTS Portable Calibration 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.
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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 0ee4ebfd-d394-4f2b-8d55-b0ce73d1de8d 34 fields · synced May 29, 2026