Duns Number:108999095
Device Description: ADCUFF SPU Cuff, 1 Tube,Large Adult, Burgundy, No Conn, 20/pkg
Catalog Number
8450-12X-1
Brand Name
Adcuff™
Version/Model Number
8450-12X-1
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)
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
ac8ded78-d9c3-498a-bb86-ce77393e0a21
Public Version Date
July 22, 2019
Public Version Number
2
DI Record Publish Date
May 04, 2018
Package DI Number
00634782586294
Quantity per Package
5
Contains DI Package
00634782886295
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 |