Identity
- Trade Name
- OmniLab Connect System EUDAMEDOmniLab Connect FDA UDI
- Generic Name
- Clinical laboratory information system FDA UDI
- Device Name
- OmniLab Connect EUDAMEDOmniLab Connect System FDA UDI
- Model / Reference
- 1111076 EUDAMEDOmniLab Connect System FDA UDI
- Description
- OmniLab Connect System FDA UDI
Identifiers
- Catalog Number
- 1111076 FDA UDI
- Primary DI / UDI-DI
- 00606959021501 EUDAMEDFDA UDI
- Basic UDI-DI
- 0606959BM210LH EUDAMED
- Direct Marketing DI
- 00606959021501 EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- Z12159082 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Clinical laboratory information system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
OmniLab Connect System by Respironics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0606959BM210LH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 97c959d8-764c-45ff-8503-3a420f985780 61 fields · synced Jun 18, 2026
- FDA UDI 576bd15a-9884-43d5-b8bb-3c1e31955bf3 36 fields · synced May 30, 2026