FDA.report

Polytel

Primary DI
00861700000352
Brand
Polytel
Company
Polymap Wireless
Model
"A" cable for GMA2
Catalog number
RPLYX02
Device description
Cable to be used with Polytel PWR-09-02 GMA2 to support Abbott glucose meters
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OUGMedical Device Data System

Product Code Classifications

CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00861700000352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00861700000352008617000003528617000003520861700000352

GMDN Terms

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

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
false
Manufacturing date on label
false
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 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
00861700000369Polytel"B" cable for GMA2RYPLX032017-02-15
00861700000376PolytelGMA2-L2017-03-08

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