Duns Number:315578914
Catalog Number
-
Brand Name
VentStar Breathing Bag 2L
Version/Model Number
MP02712
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTC
Product Code Name
Bag, Reservoir
Public Device Record Key
d39ff992-9973-4df8-b6b0-4e0b3d8d1d29
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 08, 2016
Package DI Number
04048675441717
Quantity per Package
25
Contains DI Package
04048675389460
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 220 |
2 | A medical device with a moderate to high risk that requires special controls. | 160 |