Duns Number:108359188
Device Description: This cable is used to connect the Polytel PWR-09-02 GMA2 unit to glucose meters from LifeS This cable is used to connect the Polytel PWR-09-02 GMA2 unit to glucose meters from LifeScan
Catalog Number
RPLYX01
Brand Name
Polytel
Version/Model Number
"L" cable for GMA2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OUG
Product Code Name
Medical Device Data System
Public Device Record Key
0596f1c3-61e1-47c0-b9c4-c8d541f29ddc
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
February 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |