Duns Number:054318779
Device Description: Blood Pressure Monitor and single channel EKG device.
Catalog Number
BP7900
Brand Name
Complete Blood Pressure Monitor +EKG
Version/Model Number
BP7900
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182579,K202228,K182579,K202228
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
59225584-0971-4dca-8c51-346d80de5ede
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
April 01, 2019
Package DI Number
10073796267909
Quantity per Package
6
Contains DI Package
00073796267902
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 | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 48 |