Duns Number:108999095
Device Description: Adcuff & Bladder 1 Tube w/Connector,Large Adult, Burgundy, LF
Catalog Number
845-12XBD-1HP
Brand Name
Adcuff™
Version/Model Number
845-12XBD-1HP
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
0c945fac-8562-46f5-92ab-300a9a898df2
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
July 31, 2020
Package DI Number
00634782599423
Quantity per Package
15
Contains DI Package
00634782098049
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 |