Identity
- Trade Name
- Umano Connect FDA UDI
- Generic Name
- Bedside monitor remote-viewing software, non-physiological parameter FDA UDI
- Device Name
- Umano Connect, model 282-0002, is designed to electronically receive bed status data in near real-time and display status of a connected ook bed. FDA UDI
- Model / Reference
- 282-0002 FDA UDI
- Description
- Umano Connect, model 282-0002, is designed to electronically receive bed status data in near real-time and display status of a connected ook bed. FDA UDI
Identifiers
- Catalog Number
- 282-0002 FDA UDI
- Primary DI / UDI-DI
- 00670482000982 FDA UDI
- FDA Product Code
- FNL FDA UDI
- GMDN Term
- Bedside monitor remote-viewing software, non-physiological parameter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5100 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bedside monitor remote-viewing software, non-physiological parameter
Umano Connect by Umano Medical Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bedside monitor remote-viewing software, non-physiological parameter.
- Cubby Beds — Sensory Medical, Inc. · Class I
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
- Umano Medical Inc
Sources (2)
- FDA UDI 417e3338-5ca4-4124-b350-66504e50ab83 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026