FDA UDI
In Commercial Distribution
🇺🇸 United States
OneTouch Ultramini
DI: 00353885008167
·
Model: 021-514
·
LifeScan Europe GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OneTouch Ultramini
- Primary DI
- 00353885008167
- Version / Model
- 021-514
- Catalog Number
- 021-514
- Company Name
- LifeScan Europe GmbH
- Labeler DUNS
- 480240820
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-13
- Public Version
- 4
- Public Version Date
- 2019-07-26
- Public Version Status
- Update
- Public Device Record Key
- 5ecb06d5-62ac-4966-b633-14a64f0bc070
Device Description
OneTouch Ultramini Blood Glucose Monitoring Meter - Warranty replacement
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
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 20353885008161 | GS1 | Shipper case | 32 | In Commercial Distribution | |
| Primary | 00353885008167 | GS1 |
Customer Contacts
- Phone
- +1(800)227-8862
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061118 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Blood Glucose measurement Level mg/dL | ||
| Device Size Text, specify | Hematocrit 30 - 55% |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Operating Altitude up to 10000 Feet
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 43 – 111 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not refrigerate
- Type
- Storage Environment Temperature
- Temperature Range
- High: 86 Degrees Fahrenheit