FDA UDI
In Commercial Distribution
🇺🇸 United States
UbiqVue
DI: B353UA2251C1
·
Model: UA2251-C
·
Lifesignals, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UbiqVue
- Primary DI
- B353UA2251C1
- Version / Model
- UA2251-C
- Company Name
- Lifesignals, Inc.
- Labeler DUNS
- 798830720
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-22
- Public Version
- 1
- Public Version Date
- 2025-04-30
- Public Version Status
- New
- Public Device Record Key
- 4957f96f-316b-4b43-897c-dcbc2906e1a3
Device Description
Holter Web Portal
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | 870.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65832 | Wireless patient monitor/sensor reporting software, professional-only | A software program intended to be installed on an off-the-shelf, computerized device (e.g., desktop computer, tablet) and used by a healthcare professional in a clinical/care setting to receive data from a noninvasive, patient-worn, wireless monitor/sensor. It is not dedicated to bedside monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B353UA2251C1 | HIBCC |
Customer Contacts
- Phone
- 510.770.6412
- [email protected]