FDA UDI
In Commercial Distribution
🇺🇸 United States
In Touch Blood Glucose Meter
DI: 00853553005035
·
Model: BG200
·
LIVONGO HEALTH, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- In Touch Blood Glucose Meter
- Primary DI
- 00853553005035
- Version / Model
- BG200
- Catalog Number
- FG00163
- Company Name
- LIVONGO HEALTH, INC
- Labeler DUNS
- 829984561
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3f406929-fa2c-48e5-9f13-85d4c24bf79f
Device Description
In Touch BG 200 Blood Glucose Meter with Charger Adapter and USB Cable
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
- 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 |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56684 | Home-use/point-of-care glucose analyser IVD, battery-powered | An exclusively battery-powered instrument intended to be used by a layperson in the home or similar environment, or by health professionals at the point-of-care, for the quantitative in vitro measurement of glucose levels in whole blood. 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 | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853553005035 | GS1 |
Customer Contacts
- Phone
- 800.945.4355
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133584 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- – 75 KiloPascal