FDA.reportPublic FDA data

Polytel GMA

Primary DI
00861700000314
Brand
Polytel GMA
Company
Polymap Wireless
Model
PWR-08-07
Device description
Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Bayer. Specific meters supported are Breeze2, Contour, Contour TS, Contour next EZ.
Published
2016-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

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
00861700000314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861700000314008617000003148617000003140861700000314

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 520 747 1811info@polymap.net

Regulatory Flags#

DUNS number
108359188
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
00861700000307Polytel GMAPWR-08-062016-08-02
00861700000321Polytel GMAPWR-08-092016-08-02
00861700000338Polytel GMA2PWR-09-022016-08-02
00861700000345Polytel"L" cable for GMA2RPLYX012017-02-15
00861700000352Polytel"A" cable for GMA2RPLYX022017-02-15
00861700000369Polytel"B" cable for GMA2RYPLX032017-02-15
00861700000376PolytelGMA2-L2017-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10041260007351TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2026-02-09
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00860015091659KetoBMKETOBM USA LLCNBW2026-01-19
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07506555400003Glucheck Self-Monitoring Blood Glucose SystemEPS BIO TECHNOLOGY CORP.NBW2026-01-02
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00850063675956metene S BLOOD GLUCOSE MONITORING SYSTEMMETENE LIMITEDNBW2025-12-24
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10385540109732CareSens S Fit BTAgaMatrix, Inc.NBW2025-11-30
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00850068074457TenoviTenovi Co.NBW2025-11-20
20385540109722CareSens S FitAGAMATRIX, INC.NBW2025-08-04