FDA UDI
In Commercial Distribution
🇺🇸 United States
Livongo Blood Glucose Meter
DI: 00853553005011
·
Model: BG300C, Kaifa DongGuan
·
LIVONGO HEALTH, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Livongo Blood Glucose Meter
- Primary DI
- 00853553005011
- Version / Model
- BG300C, Kaifa DongGuan
- Catalog Number
- FG02062
- Company Name
- LIVONGO HEALTH, INC
- Labeler DUNS
- 829984561
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-24
- Public Version
- 1
- Public Version Date
- 2020-03-03
- Public Version Status
- New
- Public Device Record Key
- d53a766e-36a8-41fb-9f36-1376b0325c78
Device Description
BG300 rev C Blood Glucose Meter, Kaifa DongGuan
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62645 | Glucose analyser IVD, home-use | An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853553005011 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133584 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -13 – 115 Degrees Fahrenheit
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- – 75 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit