Identity
- Trade Name
- OR Laptop FDA UDI
- Generic Name
- Patient health record information system FDA UDI
- Device Name
- Dedicated Laptop PC, part of the OR Base Station System FDA UDI
- Model / Reference
- 43-5570-003-14 FDA UDI
- Description
- Dedicated Laptop PC, part of the OR Base Station System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003118337 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Patient health record information system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient health record information system
OR Laptop by Canary Medical Usa Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient health record information system.
- Connect — LivaNova Deutschland GmbH · Class II
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- Xper Information Management System — Philips Medical Systems Nederland B.V. · Class II
- Home Monitoring Service Center — BIOTRONIK SE & Co. KG · Class III
- ELI Edit — MORTARA INSTRUMENT, INC. · Class II
- ESSENZ — LivaNova Deutschland GmbH · Class II
- Datapad — LivaNova Deutschland GmbH · Class II
- ELI Edit — MORTARA INSTRUMENT, INC. · Class II
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 |
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Manufacturer
- Manufacturer
- Canary Medical Usa Llc
Sources (1)
- FDA UDI a1066725-3338-49e4-aa14-3aaebfd6128a 33 fields · synced Jun 1, 2026