Duns Number:041674552
Device Description: Blood Pressure Unit, Pediatric
Catalog Number
-
Brand Name
MedSource Blood Pressure Unit, Pediatric
Version/Model Number
MS-BP300
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
39baeca9-ceab-4847-8e59-08d0f2b3b92a
Public Version Date
September 07, 2022
Public Version Number
3
DI Record Publish Date
June 30, 2016
Package DI Number
00840155413481
Quantity per Package
50
Contains DI Package
00816703021491
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 | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |