Duns Number:407157098
Device Description: Medisize Blue Small HMEF
Catalog Number
-
Brand Name
Medisize®
Version/Model Number
303 200 000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 12, 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
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
-
Product Code
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
a8c3efe4-75b5-40b6-9287-edc151566b67
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
October 07, 2016
Package DI Number
18717146000021
Quantity per Package
50
Contains DI Package
08717146000024
Package Discontinue Date
May 12, 2020
Package Status
Not 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 | 37 |
2 | A medical device with a moderate to high risk that requires special controls. | 26 |