FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380112995
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
BEV-FP-050
Catalog number
BEV-FP-050
Device description
Beverage Glucose Tolerance Test FP 50gm 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
OTC
false
Sterile
false
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
20885380112994PackageGS110In Commercial Distribution
50885380112995PackageGS124In Commercial Distribution
10885380112997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538011299420885380112994
5088538011299550885380112995
1088538011299710885380112997

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
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
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

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