Duns Number:062028220
Device Description: BP Replacement Cuff
Catalog Number
04-240-006
Brand Name
HealthSmart
Version/Model Number
04-240-006
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)
-
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
0e006fdb-b319-4a4b-b2e5-6fd90cc81173
Public Version Date
July 22, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10767056240060
Quantity per Package
3
Contains DI Package
30767056240064
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 206 |