Identity
- Trade Name
- Contact Gel 2ml FDA UDI
- Generic Name
- Pulse Co-oximeter probe, reusable FDA UDI
- Device Name
- The Contact Gel is required for proper CO2 gas conduction from the patient's skin to the SenTec TC Sensors. Every time a SenTec TC Sensor is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor membrane. FDA UDI
- Model / Reference
- GEL-04 FDA UDI
- Description
- The Contact Gel is required for proper CO2 gas conduction from the patient's skin to the SenTec TC Sensors. Every time a SenTec TC Sensor is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor membrane. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640121880858 FDA UDI
- FDA Product Code
- LPP FDA UDILKD FDA UDIKLK FDA UDIDQA FDA UDIDPZ FDA UDI
- GMDN Term
- Pulse Co-oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2500 FDA UDI868.2480 FDA UDI870.2700 FDA UDI870.2710 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2 Milliliter FDA UDI
Contact Gel 2ml by Sentec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Sentec, Inc.
Sources (1)
- FDA UDI e1bd03c4-1db1-4406-855d-fdd294217648 37 fields · synced May 30, 2026