Duns Number:344030150
Device Description: Blood pressure cuff for Mobil-O-Graph Size XS 14-20 cm circumference
Catalog Number
M25550200
Brand Name
ABPM-cuff
Version/Model Number
size XS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 17, 2017
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)
Yes
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
fd76555a-7713-449b-9482-6268a3645e77
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
October 28, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 60 |