FDA UDI
In Commercial Distribution
🇺🇸 United States
Livongo Blood Pressure Welcome Kit
DI: 00853553005394
·
Model: Livongo
·
LIVONGO HEALTH, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Livongo Blood Pressure Welcome Kit
- Primary DI
- 00853553005394
- Version / Model
- Livongo
- Catalog Number
- KIT02231
- Company Name
- LIVONGO HEALTH, INC
- Labeler DUNS
- 829984561
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-14
- Public Version
- 2
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- 967f3489-ceaa-4ea6-950a-b444c9ae0b33
Device Description
Livongo Blood Pressure Monitor UA-651BLE-LIV, 1 Livongo Cuff (UA-420), 1 Livongo Carrying Case, 1 Instruction manual, 1 Quick Start Guide, 1 Welcome Card, 4 AA Batteries
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16173 | Automatic-inflation electronic sphygmomanometer, non-portable | An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853553005394 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 800 – 1060 millibar
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 15 – 85 Percent (%) Relative Humidity