Duns Number:022721133
Device Description: NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Double Tube7-24-2020 original NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Double Tube7-24-2020 original Primary DI above was entered in error. The correct DI is 00607411911415.
Catalog Number
ZNC4702L-1..
Brand Name
N/A
Version/Model Number
ZNC4702L-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 24, 2020
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
Product Code
DXQ
Product Code Name
blood pressure cuff
Public Device Record Key
0052af6f-cd54-44e6-ba63-ee2fec760ae3
Public Version Date
July 27, 2020
Public Version Number
4
DI Record Publish Date
February 24, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |