Identity
- Trade Name
- Care Orchestrator FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- Care Orchestrator, Medical equipment clinical data interfacing software FDA UDI
- Model / Reference
- 1.24 FDA UDI
- Description
- Care Orchestrator, Medical equipment clinical data interfacing software FDA UDI
Identifiers
- Catalog Number
- 1126366 FDA UDI
- Primary DI / UDI-DI
- 00606959057760 FDA UDI
- FDA Product Code
- MNS FDA UDICAW FDA UDIBZD FDA UDINOU FDA UDIMNT FDA UDICBK FDA UDI
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI868.5440 FDA UDI868.5905 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical equipment clinical data interfacing software
Care Orchestrator by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical equipment clinical data interfacing software.
- Atellica Connect — Siemens Healthcare Diagnostics · Class I
- RALS — Abbott Rapid Diagnostics Informatics, Inc. · Class I
- Intesys Clinical Suite — SPACELABS HEALTHCARE (WASHINGTON), INC · Class I
- Sickbay Clinical Platform — Medical Informatics Corp · Class II
- RALS — Abbott Rapid Diagnostics Informatics, Inc. · Class I
- Caseview — PHYSIO-CONTROL, Inc. · Class I
- RALS — Abbott Rapid Diagnostics Informatics, Inc. · Class I
- ZOLL ePCR iOS — Zoll Medical Corporation
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
- Respironics, Inc.
Sources (1)
- FDA UDI 62f95688-f0ef-42f5-84e1-85291e2d7c0a 35 fields · synced Jun 8, 2026