DEVICE: OneTouch Ultramini (00353885000482)
Device Identifier (DI) Information
OneTouch Ultramini
021-208
In Commercial Distribution
021-208
LifeScan Europe GmbH
021-208
In Commercial Distribution
021-208
LifeScan Europe GmbH
OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
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Active | false |
| 37243 | Manual blood lancing device, reusable |
A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.
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Active | false |
| 45142 | Blood lancing device tip |
A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K061118 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: less than 86 Degrees Fahrenheit |
| Special Storage Condition, Specify: Operating Altitude up to 10000 Feet |
| Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature: between 43 and 111 Degrees Fahrenheit |
| Special Storage Condition, Specify: Do not refrigerate |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Needle Gauge: 30 Gauge |
| Device Size Text, specify: Blood Glucose measurement Level mg/dL |
| Device Size Text, specify: Hematocrit 30 - 55% |
Device Record Status
3cf89a12-b39c-4cb9-b305-01b42ef36787
July 26, 2019
4
September 13, 2017
July 26, 2019
4
September 13, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 20353885000486 | 4 | 00353885000482 | In Commercial Distribution | Shipper case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| NDC/NHRIC | 53885-208-01 |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)227-8862
XX@XX.XX
XX@XX.XX