DEVICE: OneTouch Ultra2 (00353885000277)

Device Identifier (DI) Information

OneTouch Ultra2
021-098
In Commercial Distribution
021-098
Cilag GmbH International
00353885000277
GS1

1
481902997 *Terms of Use
OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra Blue Test strip
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Device Characteristics

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

GMDN

[?]

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

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

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

ef4572f2-500b-49d7-b01a-782bf5a9eacd
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
20353885000271 4 00353885000277 In Commercial Distribution Shipper case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
NDC/NHRIC 53885-448-01
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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

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Yes
Yes
Yes
Yes
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Customer Contact

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