Duns Number:407157098
Device Description: Medisize Blue Big HMEF with Catheter Mount
Catalog Number
-
Brand Name
Medisize®
Version/Model Number
433 105 010
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
bcc4585e-699f-4386-8d16-fc7f1612441d
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
October 07, 2016
Package DI Number
28717146000493
Quantity per Package
4
Contains DI Package
18717146000496
Package Discontinue Date
May 12, 2020
Package Status
Not 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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |