FDA.reportPublic FDA data

GenUltimate

Primary DI
00850015460036
Brand
GenUltimate
Company
PHARMA TECH SOLUTIONS, INC.
Model
300-25
Device description
Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters
Published
2020-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
10850015460033PackageGS112In Commercial Distribution
20850015460030PackageGS118In Commercial Distribution
00850015460036PrimaryGS10
00868906000131Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001546003310850015460033
2085001546003020850015460030
00850015460036008500154600368500154600360850015460036
00868906000131008689060001318689060001310868906000131

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
805-446-2973kberman@decisiondiagnostics.net

Regulatory Flags#

DUNS number
829145387
Device count
250
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
00860002137971Alltara Zephyr!103-102019-09-09
10860002137923GenUltimate Zephyr!104-502019-09-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCCGA2026-08-13
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
05700693930978ABL90 FLEXRadiometer Medical ApSCGA2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGA2026-07-09
05700699446572SP90Radiometer Medical ApSCGA2026-07-09
05700699447579SP90Radiometer Medical ApSCGA2026-07-09
05700699461056SC90Radiometer Medical ApSCGA2026-07-09
05700699461087SC90Radiometer Medical ApSCGA2026-07-09
05700699461094SC90Radiometer Medical ApSCGA2026-07-09
05700699461100SC90Radiometer Medical ApSCGA2026-07-09
05700699461131SC90Radiometer Medical ApSCGA2026-07-09
05700699461605SC90Radiometer Medical ApSCGA2026-07-09
MHC1101665142EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
MHC18073002EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
00311917064635WalgreensWALGREEN CO.CGA2025-06-20
00353885013000OneTouch UltraLifeScan U.S. LLCCGA2025-06-20
00194346219254ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00194346219261ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00054749005710i-STAT G CartridgeABBOTT POINT OF CARE INC.CGA2024-04-30
00381932488013Assy Vial, eGLU, 13 ct.POLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-07-30
MHC19902833042Members MarkWAL-MART STORES, INC.CGA2023-05-10
MHC19902833062Members MarkWAL-MART STORES, INC.CGA2023-04-18
MHC19902833072Members MarkWAL-MART STORES, INC.CGA2023-04-18
00381934748016Assy Vial, eGLU Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-03-25
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24