DEVICE: GenUltimate! (00868906000100)
Device Identifier (DI) Information
GenUltimate!
100-50
In Commercial Distribution
100-50
PHARMA TECH SOLUTIONS, INC.
100-50
In Commercial Distribution
100-50
PHARMA TECH SOLUTIONS, INC.
Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47654 | 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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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CGA | Glucose Oxidase, Glucose |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9368f0cd-a038-444b-9305-a96944a294d6
March 29, 2018
2
September 01, 2016
March 29, 2018
2
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00868906000131
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
805-446-2973
intermania@aol.com
intermania@aol.com