Duns Number:022721133
Device Description: ComfortCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube
Catalog Number
ZCC4401MQM-1
Brand Name
N/A
Version/Model Number
ZCC4401MQM-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
K921997,K921997
Product Code
DXQ
Product Code Name
blood pressure cuff
Public Device Record Key
eaf87e45-ba2f-436a-9a22-1ca6a55faf18
Public Version Date
May 09, 2019
Public Version Number
1
DI Record Publish Date
May 01, 2019
Package DI Number
10607411971126
Quantity per Package
10
Contains DI Package
00607411971129
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 |