FDA.reportPublic FDA data

Polytel

Primary DI
00861700000376
Brand
Polytel
Company
Polymap Wireless
Model
GMA2-L
Device description
Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bluetooth 2.1 connectivity for telehealth applications. This is built on a PWR-09-02 device, which an also support other glucose meter families if appropriate cables are provided: "B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ, "A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite
Published
2017-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861700000376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861700000376008617000003768617000003760861700000376

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108359188
Device count
1
DM exempt
false
Premarket exempt
true
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
00861700000314Polytel GMAPWR-08-072016-08-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28
03770034761037HOPACKHOPI MEDICALOUG2026-01-28
03770034761044SATCHELHOPI MEDICALOUG2026-01-28
05056190500658SafeIDVISION RT LIMITEDOUG2025-12-23
00850064210286ANNE Link MobileSibel Health Inc.OUG2025-12-11
15099590799243MicroScanBeckman Coulter, Inc.OUG2025-12-08
15099590799250MicroScanBeckman Coulter, Inc.OUG2025-12-08
15099590807146MicroScanBeckman Coulter, Inc.OUG2025-12-08
00199284197749ActuviActuvi LLCOUG2025-12-02
04260658860234myoncareONCARE GmbHOUG2025-11-26
07350149360026PD Care SystemPainDrainer ABOUG2025-11-13
04961333255696Digital Capture v3.7.0PENTAX OF AMERICA, INC.OUG2025-09-12