Duns Number:013649151
Device Description: NiBP Cuff, Single Lumen, Adult-L
Catalog Number
989803182651
Brand Name
MR Patient Care Adult-Long NBP Cuff
Version/Model Number
Adult-Long NBP Cuff
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
DXN
Product Code Name
System, measurement, blood-pressure, non-invasive
Public Device Record Key
b7a97e0b-f780-4b94-8f31-4f0ec5d39154
Public Version Date
August 22, 2022
Public Version Number
3
DI Record Publish Date
May 31, 2021
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 | 17 |
2 | A medical device with a moderate to high risk that requires special controls. | 650 |
U | Unclassified | 4 |