FDA UDI
In Commercial Distribution
🇺🇸 United States
Umano Connect
DI: 00670482000982
·
Model: 282-0002
·
Umano Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Umano Connect
- Primary DI
- 00670482000982
- Version / Model
- 282-0002
- Catalog Number
- 282-0002
- Company Name
- Umano Medical Inc
- Labeler DUNS
- 249675476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-04
- Public Version
- 1
- Public Version Date
- 2025-08-12
- Public Version Status
- New
- Public Device Record Key
- 417e3338-5ca4-4124-b350-66504e50ab83
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | General Hospital | 880.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64513 | Bedside monitor remote-viewing software, non-physiological parameter | An application software program intended to be used by a healthcare professional to collect, in real-time, non-physiologic data (e.g., intravenous infusion rates, patient mood, patient position) from a bedside monitor (in a healthcare facility or in the home), to facilitate remote patient monitoring, communication, and event notifications for healthcare providers. It is not intended to collect physiological data. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00670482000982 | GS1 |