Duns Number:108999095
Device Description: Pro's Combo 776/647 Kit,Adult, Black
Catalog Number
776-647BKKIT5
Brand Name
Pro's Combo V™
Version/Model Number
776-647BKKIT5
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"
Yes
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
-
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
dc584a0b-e035-4c95-8606-231f8a4070f1
Public Version Date
November 02, 2020
Public Version Number
1
DI Record Publish Date
October 24, 2020
Package DI Number
00634782599843
Quantity per Package
12
Contains DI Package
00634782098452
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2395 |
2 | A medical device with a moderate to high risk that requires special controls. | 1769 |