DEVICE: OneTouch Ultra Blue (00353885009713)

Device Identifier (DI) Information

OneTouch Ultra Blue
022-895
In Commercial Distribution
022-895
Cilag GmbH International
00353885009713
GS1

100
481902997 *Terms of Use
OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters
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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
CGA GLUCOSE OXIDASE, 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: Do Not Refrigerate
Special Storage Condition, Specify: Store your test strips in their original vial only.
Special Storage Condition, Specify: Use within 6 months of opening test strip vial.
Storage Environment Temperature: less than 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

e18ead12-4fe9-4ac4-9de6-a1db8fefa329
March 29, 2018
2
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
20353885009717 24 00353885009713 In Commercial Distribution Shipper case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
NDC/NHRIC 53885-245-10
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Unit of Use DI

[?]
Unit of Use DI Number: 80353885009719 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(800)227-8862
XX@XX.XX
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