Duns Number:134472476
Catalog Number
-
Brand Name
Regard™
Version/Model Number
243449
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
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
K080189,K080189
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
991b88b6-8e0f-4ae1-a888-29c503d1cf44
Public Version Date
October 21, 2020
Public Version Number
3
DI Record Publish Date
October 30, 2019
Package DI Number
10326053104357
Quantity per Package
20
Contains DI Package
20326053104354
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 305 |
2 | A medical device with a moderate to high risk that requires special controls. | 558 |