FDA.reportPublic FDA data

GenUltimate Zephyr!

Primary DI
10860002137923
Brand
GenUltimate Zephyr!
Company
PHARMA TECH SOLUTIONS, INC.
Model
104-50
Device description
Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters
Published
2019-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103542000GENSTRIP TEST STRIP MODEL 100-201Shasta Technologies, LLC2012-11-30NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860002137916PackageGS118In Commercial Distribution
10860002137923PackageGS124In Commercial Distribution
00860002137926PrimaryGS10
00860002137940Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000213791610860002137916
1086000213792310860002137923
00860002137926008600021379268600021379260860002137926
00860002137940008600021379408600021379400860002137940

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
805-446-2973intermania@aol.com

Regulatory Flags#

DUNS number
829145387
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002137926GenUltimate Zephyr!104-502019-09-09
00860002137933GenUltimate Zephyr!104-102019-09-09
00860002137964Alltara Zephyr!103-502019-09-09
00850015460036GenUltimate 300-252020-01-10
00860002137971Alltara Zephyr!103-102019-09-09
20860002137937GenUltimate Zephyr!104-102019-09-09
20860002137968Alltara Zephyr!103-502019-09-09
00867396000317FireflyCatalog Number: 200-10Catalog Number: 200-102017-02-14
00867396000324GenUltimate!Catalog Number: 100-10100-102017-01-24
00868906000100GenUltimate!100-50100-502016-09-01

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