DEVICE: GenUltimate! (00868906000100)

Device Identifier (DI) Information

GenUltimate!
100-50
In Commercial Distribution
100-50
PHARMA TECH SOLUTIONS, INC.
00868906000100
GS1

50
829145387 *Terms of Use
Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Home-use/point-of-care glucose rapid test/blood pressure system analyser A portable, battery-powered instrument used with other devices (e.g., reagents, test strips, a blood pressure cuff, and accessories) to semi-quantitatively measure glucose in a specimen of whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure. The measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. The device is normally available [non-prescription] over-the-counter (OTC) for home-use, but may also be used in a clinical setting for multi-patient monitoring of blood glucose and blood pressure.
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FDA Product Code

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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9368f0cd-a038-444b-9305-a96944a294d6
March 29, 2018
2
September 01, 2016
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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
10868906000121 18 10868906000107 In Commercial Distribution Case
10868906000107 24 00868906000100 In Commercial Distribution Inner Pack
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 00868906000131 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
No
Yes
Yes
No CLOSE

Customer Contact

[?]
805-446-2973
intermania@aol.com
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