FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380113079
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
BEV-O-100
Catalog number
BEV-O-100
Device description
Beverage Glucose Tolerance Test Orange 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
20885380113076PackageGS110In Commercial Distribution
50885380113077PackageGS124In Commercial Distribution
10885380113079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538011307620885380113076
5088538011307750885380113077
1088538011307910885380113079

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
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

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