FDA.report

CVS Health

Primary DI
10050428542146
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
8000-10328
Device description
Test Strips, CVS Health, Advanced, 50CT, 100CT, 200CT
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00050428344378PackageGS11In Commercial Distribution
00050428410820PackageGS12In Commercial Distribution
00050428542149PackageGS14In Commercial Distribution
10050428344375PackageGS124In Commercial Distribution
10050428410827PackageGS112In Commercial Distribution
10050428542146PackageGS112In Commercial Distribution
30050428344379PrimaryGS10
40050428344376Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428344378000504283443780504283443780050428344378
00050428410820000504284108200504284108200050428410820
00050428542149000504285421490504285421490050428542149
1005042834437510050428344375
1005042841082710050428410827
1005042854214610050428542146
3005042834437930050428344379
4005042834437640050428344376

GMDN Terms

TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature8 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
062312574
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
false
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 DIBrandModelCatalogPublished
00050428044940CVS6158032026-05-26
00050428045770CVS6162732026-05-26
00050428046715CVS6162742026-05-26
00050428344781CVS0504283447812026-05-25
20050428020849CVS HealthCVS376561V22026-03-23
00050428339770CVS Health16CVS015073291982026-03-20
10050428001025CVS 797412BM22-12026-02-27
00050428005408CVS 841855WF032026-02-13
00050428005415CVS 845712WF132026-02-13
00050428005422CVS 837160WF232026-02-13
40050428029495CVS6354782026-02-13
00050428057186CVSHealth1017042026-02-04
00050428073421CVSHealth1044172026-02-04
00050428080863CVSHealth1059932026-02-04
00050428005583CVS 689466LB152026-01-28
10050428005603CVS 689509LB262026-01-26
10050428005610CVS 689573LB462026-01-23
10050428273484CVS Health TamponsBCVGC32(L/R)2025-12-31
00050428005842CVS 695535BM332025-12-11
00050428005804CVS 275172BF7222025-12-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850080988114AUVONUAN HEALTHCARE LIMITEDNBW2026-03-02
00860003164518RosieSouthern Life Systems, Inc.NBW2026-03-02
00860003164570RosieSouthern Life Systems, Inc.NBW2026-03-02
00810079240531Teladoc Health, Inc.Teladoc Health, Inc.NBW2026-02-17
00810079240548Teladoc Health, Inc.Teladoc Health, Inc.NBW2026-02-17
00810079240555Teladoc Health, Inc.Teladoc Health, Inc.NBW2026-02-17
10041260007351TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2026-02-09
00850080988091AUVONUAN HEALTHCARE LIMITEDNBW2026-02-06
00850001462136GOJJI Plus TestNGo MULTIFUNCTION (GLUC-KETONE) METERGOJJI, INC.NBW2026-02-01
00860015091659KetoBMKETOBM USA LLCNBW2026-01-19
00860015091666KetoBMKETOBM USA LLCNBW2026-01-19
00850068074174TenoviTenovi Co.NBW2026-01-02
00850068074266TenoviTenovi Co.NBW2026-01-02
07506555400003Glucheck Self-Monitoring Blood Glucose SystemEPS BIO TECHNOLOGY CORP.NBW2026-01-02
27506555400014Glucheck Blood Glucose Test StripEPS BIO TECHNOLOGY CORP.NBW2026-01-02
00850063675956metene S BLOOD GLUCOSE MONITORING SYSTEMMETENE LIMITEDNBW2025-12-24
10850044118776iHealthIHEALTH LAB INC.NBW2025-12-19
10850044118806iHealthIHEALTH LAB INC.NBW2025-12-19
10856362005156iHealthIHEALTH LAB INC.NBW2025-12-19
00199284201354SureMediks B-ketone & blood glucose monitoring systemRasimo Systems LLCNBW2025-12-05
00816042016066FORAFORA CARE INC.NBW2025-12-05
00883489002662iGlucose Touch Blood Glucose MeterBIONIME CORPORATIONNBW2025-12-04
00883489002686iGlucose Touch Blood Glucose Test StripBIONIME CORPORATIONNBW2025-12-04
00883489002709iGlucose Touch Control SolutionBIONIME CORPORATIONNBW2025-12-04
10385540109732CareSens S Fit BTAgaMatrix, Inc.NBW2025-11-30
00050428284391CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
00050428284483CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10075450843573TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2025-11-26
00850068074457TenoviTenovi Co.NBW2025-11-20
20385540109722CareSens S FitAGAMATRIX, INC.NBW2025-08-04