Duns Number:177939027
Device Description: Critikon Soft Cuf Two Tube Submin, Thigh
Catalog Number
-
Brand Name
Critikon
Version/Model Number
2406
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2019
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
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
K032821,K032821
Product Code
NPP
Product Code Name
Reprocessed Blood Pressure Cuff
Public Device Record Key
02032670-3a81-432d-8bc0-93fb77c1d4c4
Public Version Date
March 19, 2021
Public Version Number
4
DI Record Publish Date
September 28, 2016
Package DI Number
30817357021746
Quantity per Package
20
Contains DI Package
10817357021742
Package Discontinue Date
March 19, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 178 |