Duns Number:178440426
Device Description: CHILD CUFF DUAL LUMEN LATEX FREE, CUFF SIZE 13-21 CM
Catalog Number
-
Brand Name
Blood Pressure Cuff
Version/Model Number
80031DC
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
K143728
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
57654a6a-b2ae-4f6f-af62-460e0351240b
Public Version Date
March 29, 2021
Public Version Number
5
DI Record Publish Date
June 20, 2017
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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 230 |