DEVICE: OneTouch Verio (00353885008716)
Device Identifier (DI) Information
OneTouch Verio
022-657
In Commercial Distribution
022-657
LifeScan Europe GmbH
022-657
In Commercial Distribution
022-657
LifeScan Europe GmbH
OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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 |
62537 | Glucose monitoring system IVD, home-use |
A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; 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.
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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 |
LFR | Glucose dehydrogenase, glucose |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K131363 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Operating Altitude up to 10000 Feet |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit |
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Hematocrit 20 - 60% |
Device Size Text, specify: Blood Glucose measurement Level mg/dL |
Needle Gauge: 30 Gauge |
Device Record Status
43e67605-5523-4b5d-806a-d3eb3eb8b88e
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 |
---|---|---|---|---|---|
20353885008710 | 4 | 00353885008716 | In Commercial Distribution | Shipper case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
NDC/NHRIC | 53885-657-01 |
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(888)567-3003
XX@XX.XX
XX@XX.XX