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Standard Starter Set (without Service Gas)
FDA UDIEUDAMEDClass II (US FDA UDI)
by Sentec, Inc.
Identity
- Trade Name
- Standard Starter Set (without Service Gas) FDA UDI
- Generic Name
- Transcutaneous blood gas monitoring system FDA UDI
- Device Name
- Standard Starter Set (without Service Gas) contains: Ear Clips (EC-MI) Multi-Site Attachment Rings for mature/intact skin (MAR-MI) Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF) Membrane Changer tool (reloadable) (MC-R) Contact Gel (GEL-04) FDA UDI
- Model / Reference
- SSET_nG FDA UDI
- Description
- Standard Starter Set (without Service Gas) contains: Ear Clips (EC-MI) Multi-Site Attachment Rings for mature/intact skin (MAR-MI) Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF) Membrane Changer tool (reloadable) (MC-R) Contact Gel (GEL-04) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640121880308 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Standard Starter Set (without Service Gas) by Sentec, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sentec, Inc.
Sources (2)
- FDA UDI 1790f7e3-d6a5-4475-ac27-a30e261bc2db 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026