Duns Number:763477098
Device Description: Accessory Plug Type A & USB Cable Replacement Kit
Catalog Number
71613
Brand Name
FreeStyle
Version/Model Number
71613
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 15, 2021
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
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Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
OUG
Product Code Name
Medical device data system
Public Device Record Key
15592e46-19c4-4ab7-846a-b236772fc1ce
Public Version Date
January 15, 2021
Public Version Number
3
DI Record Publish Date
February 28, 2018
Package DI Number
30357599000517
Quantity per Package
50
Contains DI Package
00357599000516
Package Discontinue Date
January 15, 2021
Package Status
Not in Commercial Distribution
Package Type
Case
| 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. | 2 |