Duns Number:094651270
Device Description: Disposable umbilical cord clamp, cut, and blood collection device.
Catalog Number
CRD-201
Brand Name
Cordguard®
Version/Model Number
II
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
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
K954619,K954619
Product Code
KNA
Product Code Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Public Device Record Key
78297a2c-1ea7-434d-ba01-50e69df6c41f
Public Version Date
December 18, 2019
Public Version Number
5
DI Record Publish Date
June 21, 2017
Package DI Number
H671CRD2011
Quantity per Package
10
Contains DI Package
H671CRD2010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |