GenUltimate Zephyr!

GUDID 20860002137937

Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters

PHARMA TECH SOLUTIONS, INC.

Glucose IVD, kit, electrometry
Primary Device ID20860002137937
NIH Device Record Key0aaa6c9b-2326-4918-8afd-c15304b59ae0
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenUltimate Zephyr!
Version Model Number104-10
Company DUNS829145387
Company NamePHARMA TECH SOLUTIONS, INC.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone805-446-2973
Emailintermania@aol.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002137933 [Primary]
GS100860002137940 [Unit of Use]
GS110860002137930 [Package]
Contains: 00860002137933
Package: [24 Units]
In Commercial Distribution
GS120860002137937 [Package]
Contains: 10860002137930
Package: [18 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-17
Device Publish Date2019-09-09

On-Brand Devices [GenUltimate Zephyr!]

20860002137937Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® Ultr
10860002137923Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® Ultr

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