FDA.reportPublic FDA data

Glucose Tolerance Beverage

Primary DI
20859047006018
Brand
Glucose Tolerance Beverage
Company
AZER SCIENTIFIC INCORPORATED
Model
10-FP-075
Catalog number
10-FP-075
Device description
Glucose Tolerance Beverage, Fruit Punch, 75 Gram
Published
2018-12-31
Public version status
New
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
K042183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042183000GLUCOSE TOLERANCE BEVERAGEEver Scientific2004-10-27MRV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20859047006018PrimaryGS10
00859047006014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085904700601820859047006018
00859047006014008590470060148590470060140859047006014

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
137459512
Device count
24
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843792144275Azer Scientific1ES864312020-03-30
20859047006001Glucose Tolerance Beverage10-FP-05010-FP-0502018-12-31
20859047006025Glucose Tolerance Beverage10-FP-10010-FP-1002018-12-31
20859047006032Glucose Tolerance Beverage10-LL-05010-LL-0502018-12-31
20859047006049Glucose Tolerance Beverage10-LL-07510-LL-0752018-12-31
20859047006056Glucose Tolerance Beverage10-LL-10010-LL-1002018-12-31
20859047006063Glucose Tolerance Beverage10-O-05010-O-0502018-12-31
20859047006070Glucose Tolerance Beverage10-O-07510-O-0752018-12-31
20859047006087Glucose Tolerance Beverage10-O-10010-O-1002018-12-31
20859047006094Glucose Tolerance Beverage10-SP-05010-SP-0502018-12-31
20859047006100Glucose Tolerance Beverage10-SP-10010-SP-1002018-12-31

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
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
00613647000748FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.MRV2016-09-24