GenUltimate Zephyr! - Value Priced Test Strips for use with - PHARMA TECH SOLUTIONS, INC.

Duns Number:829145387

Device Description: Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® Ult Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters

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More Product Details

Catalog Number

-

Brand Name

GenUltimate Zephyr!

Version/Model Number

104-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K103542,K103542,K103542,K103542

Product Code Details

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

0aaa6c9b-2326-4918-8afd-c15304b59ae0

Public Version Date

September 17, 2019

Public Version Number

1

DI Record Publish Date

September 09, 2019

Additional Identifiers

Package DI Number

20860002137937

Quantity per Package

18

Contains DI Package

10860002137930

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-