Duns Number:080935429
Device Description: Ezee Nest Smpl Cup Roche
Catalog Number
4095000
Brand Name
NA
Version/Model Number
4095000
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KYW
Product Code Name
CONTAINER, LIQUID MEDICATION, GRADUATED
Public Device Record Key
e1dc8240-a5b2-4204-aa51-7dd7a2e05d72
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 27, 2018
Package DI Number
20884521162010
Quantity per Package
5000
Contains DI Package
10884521162013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |