Duns Number:022721133
Device Description: DuraCheck Blood pressure cuff, reusable, adult - Single Tube
Catalog Number
ZDC4301F-1
Brand Name
N/A
Version/Model Number
ZDC4301F-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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080366,K080366
Product Code
DXQ
Product Code Name
blood pressure cuff
Public Device Record Key
ec49b41e-5777-4bc2-846c-384f57f3be19
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 12, 2018
Package DI Number
10607411951296
Quantity per Package
5
Contains DI Package
00607411951299
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |