FDA.reportPublic FDA data

PRODIGY Astro PRO Blood Glucose Monitoring System

Primary DI
00384840517752
Brand
PRODIGY Astro PRO Blood Glucose Monitoring System
Company
Prodigy Diabetes Care, LLC
Model
051775
Catalog number
051775
Device description
PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients
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
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30384840517753PackageGS110In Commercial Distribution
00384840517752PrimaryGS10
08484-0517-75SecondaryNDC/NHRIC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038484051775330384840517753
00384840517752003848405177523848405177520384840517752

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
1
Lot or batch
true
Serial number
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
00384840517004PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips0517000517002020-09-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27
00010939958617TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2023-09-12
00010939958693TRUE METRIXTRIVIDIA HEALTH, INC.NBW2023-09-12
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
00011822002783TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2021-08-31
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11