Identity
- Trade Name
- V-Sign™ Sensor 2 FDA UDI
- Generic Name
- Transcutaneous blood gas monitoring system FDA UDI
- Device Name
- Digital Sensor for non-invasive and continuous measurement of transcutaneous carbon dioxide partial pressure and pulse oximetry. Suitable for adult, pediatric and neonatal patients. FDA UDI
- Model / Reference
- VS-A/P/N FDA UDI
- Description
- Digital Sensor for non-invasive and continuous measurement of transcutaneous carbon dioxide partial pressure and pulse oximetry. Suitable for adult, pediatric and neonatal patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640121880513 FDA UDI
- FDA Product Code
- DPZ FDA UDIDQA FDA UDIKLK FDA UDILKD FDA UDILPP FDA UDI
- GMDN Term
- Transcutaneous blood gas monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2710 FDA UDI870.2700 FDA UDI868.2500 FDA UDI868.2480 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulse Co-oximeter probe, reusableTranscutaneous blood gas monitor sensorTranscutaneous blood gas monitoring system
V-Sign™ Sensor 2 by Sentec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041548 also covers:
- OxiVenT™ Sensor — Sentec, Inc.
- PSG Cable A — Sentec, Inc.
- PSG Cable B — Sentec, Inc.
- PSG Cable C — Sentec, Inc.
- PSG Cable D — Sentec, Inc.
- PSG Cable E — Sentec, Inc.
- PSG Cable F — Sentec, Inc.
- PSG Cable G — Sentec, Inc.
- PSG Cable H — Sentec, Inc.
- PSG Cable J — Sentec, Inc.
- PSG Cable K — Sentec, Inc.
- PSG Cable L — Sentec, Inc.
K071672 also covers:
- OxiVenT™ Sensor — Sentec, Inc.
- PSG Cable A — Sentec, Inc.
- PSG Cable B — Sentec, Inc.
- PSG Cable C — Sentec, Inc.
- PSG Cable D — Sentec, Inc.
- PSG Cable E — Sentec, Inc.
- PSG Cable F — Sentec, Inc.
- PSG Cable G — Sentec, Inc.
- PSG Cable H — Sentec, Inc.
- PSG Cable J — Sentec, Inc.
- PSG Cable K — Sentec, Inc.
- PSG Cable L — Sentec, Inc.
K101690 also covers:
- OxiVenT™ Sensor — Sentec, Inc.
- PSG Cable A — Sentec, Inc.
- PSG Cable B — Sentec, Inc.
- PSG Cable C — Sentec, Inc.
- PSG Cable D — Sentec, Inc.
- PSG Cable E — Sentec, Inc.
- PSG Cable F — Sentec, Inc.
- PSG Cable G — Sentec, Inc.
- PSG Cable H — Sentec, Inc.
- PSG Cable J — Sentec, Inc.
- PSG Cable K — Sentec, Inc.
- PSG Cable L — Sentec, Inc.
K151329 also covers:
- OxiVenT™ Sensor — Sentec, Inc.
- PSG Cable A — Sentec, Inc.
- PSG Cable B — Sentec, Inc.
- PSG Cable C — Sentec, Inc.
- PSG Cable D — Sentec, Inc.
- PSG Cable E — Sentec, Inc.
- PSG Cable F — Sentec, Inc.
- PSG Cable G — Sentec, Inc.
- PSG Cable H — Sentec, Inc.
- PSG Cable J — Sentec, Inc.
- PSG Cable K — Sentec, Inc.
- PSG Cable L — Sentec, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sentec, Inc.
Sources (1)
- FDA UDI 270e8f46-5ead-462e-bfd5-21e848db0080 35 fields · synced Jun 1, 2026