Identity
- Trade Name
- OmniLab Connect FDA UDI
- Generic Name
- Clinical laboratory information system FDA UDI
- Device Name
- OmniLab Connect System, Brazil FDA UDI
- Model / Reference
- OmniLab Connect System, BR FDA UDI
- Description
- OmniLab Connect System, Brazil FDA UDI
Identifiers
- Catalog Number
- BR1111076 FDA UDI
- Primary DI / UDI-DI
- 00606959043466 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Clinical laboratory information system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
OmniLab Connect by Respironics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA UDI eba12f76-3dea-48fb-ae3c-9362ad358fe7 37 fields · synced May 29, 2026