DEVICE: OneTouch Verio (00353885010030)

Device Identifier (DI) Information

OneTouch Verio
022-978
In Commercial Distribution
022-978
Cilag GmbH International
00353885010030
GS1

50
481902997 *Terms of Use
OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood glucose testing with the OneTouch Verio Family of Meters.For DME Beneficiaries Only
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Glucose IVD, kit, electrometry A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.
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FDA Product Code

[?]
Product Code Product Code Name
LFR Glucose dehydrogenase, glucose
NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110637 000
K120708 000
K131363 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Discard 6 months after opening
Special Storage Condition, Specify: Store your test strips in the vial only
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

fac5fd32-40be-4166-a229-0937ee22041a
July 06, 2018
3
September 13, 2017
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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
20353885010034 240 00353885010030 In Commercial Distribution Shipper case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
NDC/NHRIC 53885-838-01
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Unit of Use DI

[?]
Unit of Use DI Number: 80353885010036 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(888)567-3003
XX@XX.XX
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