Duns Number:023904428
Device Description: SPHYG CHILD NAVY
Catalog Number
-
Brand Name
McKesson
Version/Model Number
775-9CNMM
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
-
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
d65d62c3-a834-4a18-96f7-4431b8f5e012
Public Version Date
September 21, 2018
Public Version Number
1
DI Record Publish Date
August 21, 2018
Package DI Number
40612479234039
Quantity per Package
20
Contains DI Package
10612479234021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |