DEVICE: OneTouch Verio Flex (00353885011846)

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Device Record History
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Device Identifier (DI) Information
OneTouch Verio Flex
024045
In Commercial Distribution
024-045
LifeScan Europe GmbH
00353885011846
GS1

1
480240820 *Terms of Use
OneTouch Verio Flex Blood Glucose Monitoring System.
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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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NBW System, Test, Blood Glucose, Over The Counter
LFR Glucose Dehydrogenase, Glucose
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keep away from direct sunlight and heat
Special Storage Condition, Specify: Store your test strips in the vial only
Special Storage Condition, Specify: Operating Altitude up to 10000 Feet
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Hematocrit 20 - 60%
Device Size Text, specify: Blood Glucose measurement Level mg/dL
Needle Gauge: 30 Gauge
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Device Record Status
7be8f57b-7845-40f1-ab17-a59f7462a983
September 02, 2022
2
March 13, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20353885011840 10 00353885011846 In Commercial Distribution shipper case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
NDC/NHRIC 53885-045-01
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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