FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380113017
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
BEV-FP-100
Catalog number
BEV-FP-100
Device description
Beverage Glucose Tolerance Test FP 100gm 10oz 24bt/cs
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRVDRINK, GLUCOSE TOLERANCE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRVDrink, Glucose ToleranceClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120247000EASYDEXVineland Syrup, Inc.2012-06-21MRV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380113014PackageGS110In Commercial Distribution
50885380113015PackageGS124In Commercial Distribution
10885380113017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538011301420885380113014
5088538011301550885380113015
1088538011301710885380113017

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.

Regulatory Flags#

DUNS number
961027315
Device count
1
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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G219371020551Fresh TestFresh Test, LLCMRV2025-04-08
G219371020561Fresh TestFresh Test, LLCMRV2025-04-08
G219371020571Fresh TestFresh Test, LLCMRV2025-04-08
G219471020551Fresh TestFresh Test, LLCMRV2025-04-08
G219471020561Fresh TestFresh Test, LLCMRV2025-04-08
G219471020571Fresh TestFresh Test, LLCMRV2025-04-08
G219271020501Fresh TestFresh Test, LLCMRV2024-03-12
G219271020502Fresh TestFresh Test, LLCMRV2024-03-12
G219271020581Fresh TestFresh Test, LLCMRV2024-03-12
G219271020591Fresh TestFresh Test, LLCMRV2024-03-12
G219271020551Fresh TestFresh Test, LLCMRV2023-05-03
G219271020561Fresh TestFresh Test, LLCMRV2023-05-03
G219271020571Fresh TestFresh Test, LLCMRV2023-05-03
G219271020552Fresh TestFresh Test, LLCMRV2023-05-03
G219271020562Fresh TestFresh Test, LLCMRV2023-05-03
G219271020572Fresh TestFresh Test, LLCMRV2023-05-03
G2192710205516Fresh TestFresh Test, LLCMRV2023-03-21
G2192710205617Fresh TestFresh Test, LLCMRV2023-03-21
G2192710205718Fresh TestFresh Test, LLCMRV2023-03-21
20859047006001Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATEDMRV2018-12-31
20859047006018Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATEDMRV2018-12-31
20859047006025Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATEDMRV2018-12-31
20859047006032Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATEDMRV2018-12-31
20859047006049Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATEDMRV2018-12-31
20859047006056Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATEDMRV2018-12-31
20859047006063Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATEDMRV2018-12-31
20859047006070Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATEDMRV2018-12-31
20859047006087Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATEDMRV2018-12-31
20859047006094Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATEDMRV2018-12-31
20859047006100Glucose Tolerance BeverageAZER SCIENTIFIC INCORPORATEDMRV2018-12-31