Duns Number:196880520
Device Description: MONITOR,PROFESSIONAL,TABS, CE
Catalog Number
-
Brand Name
MONITOR,PROFESSIONAL,TABS, CE
Version/Model Number
25022CE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 14, 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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
KMI
Product Code Name
MONITOR, BED PATIENT
Public Device Record Key
6d42d54f-de08-45ae-a628-f518d054c16c
Public Version Date
October 19, 2021
Public Version Number
3
DI Record Publish Date
July 29, 2021
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 | 51 |
2 | A medical device with a moderate to high risk that requires special controls. | 94 |