Duns Number:407157098
Device Description: Medisize Breathing Circuit Neonatal, 80 inch(210cm)
Catalog Number
-
Brand Name
Medisize®
Version/Model Number
552 003 210
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
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
ead9e1f5-0cfc-4a75-813a-8955b137b9c9
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
October 07, 2016
Package DI Number
28717146000349
Quantity per Package
4
Contains DI Package
18717146000342
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 |