FDA.reportPublic FDA data

PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips

Primary DI
00384840517004
Brand
PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips
Company
Prodigy Diabetes Care, LLC
Model
051700
Catalog number
051700
Device description
PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips (50 ct)
Published
2020-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152599000PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring SystemOk Biotech Co., Ltd.2016-07-20NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00384843518008PackageGS120In Commercial Distribution
50384840517009PackageGS1200In Commercial Distribution
00384840517004PrimaryGS10
08484-0517-00SecondaryNDC/NHRIC0
10384840517001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384843518008003848435180083848435180080384843518008
5038484051700950384840517009
00384840517004003848405170043848405170040384840517004
1038484051700110384840517001

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, point-of-careA collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature39 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (800) 243-2636info@prodigymeter.com

Regulatory Flags#

DUNS number
832875905
Device count
50
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384840104006Prodigy No Coding Blood Glucose Test Strips0104000104002024-07-10
00384840518902Prodigy AutoCode Blood Glucose Monitoring System0518900518902016-09-22
00384840519008Prodigy Voice Blood Glucose Monitoring System0519000519002016-09-22
00384840528253Prodigy No Coding Blood Glucose Test Strips0528250528252016-09-21
00384840719507Prodigy Voice Blood Glucose Monitoring System0719500719502016-09-22
00384840725003Prodigy No Coding Blood Glucose Test Strips0725000725002016-09-21
00384840732001Prodigy No Coding Blood Glucose Test Strips0732000732002016-09-21
00384840761506Prodigy iConnect Blood Glucose Monitoring System0761500761502016-09-23
00384840528000Prodigy No Coding Blood Glucose Test Strips0528000528002016-09-21
00384840528109Prodigy No Coding Blood Glucose Test Strips0528100528102016-09-21
00384840751002Prodigy Combo Pre-Pack0751000751002016-09-21
00384840751507Prodigy Value Pack0751500751502016-09-21
00384840753006Prodigy No Coding Blood Glucose Test Strips0753000753002016-09-21
00384840105003Prodigy No Coding Blood Glucose Test Strips0105000105002024-07-11
00384843104003Prodigy No Coding Blood Glucose Test Strips0104000104002024-07-10
00384840750500Prodigy No Coding Blood Glucose Test Strips750500750502019-01-16
00384840518858Prodigy AutoCode Blood Glucose Monitoring System0518850518852016-09-21
00384840701205Prodigy AutoCode Blood Glucose Monitoring System0701200701202016-09-21
00384840708020Prodigy Pocket Blood Glucose Monitoring System0708020708022016-09-21
00384840743007Prodigy AutoCode Blood Glucose Monitoring System0743000743002016-11-07

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