Duns Number:003080678
Device Description: Iso-cuff Yellow Sphyg Child
Catalog Number
524762
Brand Name
Hopkins Medical Products®
Version/Model Number
524762
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXQ
Product Code Name
blood pressure cuff
Public Device Record Key
d0b52a2d-0112-49d7-9b13-ed7bea6638a5
Public Version Date
October 29, 2018
Public Version Number
1
DI Record Publish Date
September 28, 2018
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 | 96 |
2 | A medical device with a moderate to high risk that requires special controls. | 135 |