Duns Number:022721133
Device Description: VitalCheck Reusable Blood Pressure Cuff, Child (14-21 cm) - Double Tube
Catalog Number
ZVCC4402MQMF
Brand Name
N/A
Version/Model Number
ZVCC4402MQMF
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
K082630,K082630
Product Code
DXQ
Product Code Name
blood pressure cuff
Public Device Record Key
8c20aaa4-fb89-4998-bae1-e93851bed35f
Public Version Date
July 22, 2019
Public Version Number
4
DI Record Publish Date
May 12, 2017
Package DI Number
10607411940573
Quantity per Package
5
Contains DI Package
00607411940576
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 |