DEVICE: OneTouch Ultra2 (00353885010511)

Device Identifier (DI) Information

OneTouch Ultra2
023-065
In Commercial Distribution
023-065
Cilag GmbH International
00353885010511
GS1

1
481902997 *Terms of Use
OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
CGA GLUCOSE OXIDASE, GLUCOSE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K053529 000
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Sterilization

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

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Storage and Handling
Handling Environment Temperature: between 43 and 111 Degrees Fahrenheit
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Do not refrigerate
Storage Environment Temperature: less than 86 Degrees Fahrenheit
Special Storage Condition, Specify: Operating Altitude up to 10000 Feet
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Blood Glucose measurement Level mg/dL
Device Size Text, specify: Hematocrit 30 - 55%
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Device Record Status

52f967a9-e676-4d58-9342-b7bdc66032dc
July 06, 2018
3
September 13, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20353885010515 10 00353885010511 In Commercial Distribution Shipper case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
NDC/NHRIC 53885-065-01
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
Yes
No CLOSE

Customer Contact

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+1(800)227-8862
XX@XX.XX
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