Duns Number:058810771
Device Description: Ambulatory Monitoring Kit - Kendall 22450
Catalog Number
311211
Brand Name
Lynn Medical - Ambulatory Kit
Version/Model Number
311211
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
9e6dac21-5ed3-4b74-8cd8-c418e793405b
Public Version Date
November 12, 2018
Public Version Number
1
DI Record Publish Date
October 10, 2018
Package DI Number
10851491007446
Quantity per Package
50
Contains DI Package
00851491007449
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |