Duns Number:050334275
Device Description: 180"" Universal (22 mm ID) J Ventilation Breathing Circuit Without Water Trap
Catalog Number
-
Brand Name
Newport Medical
Version/Model Number
BCD43801P-EL
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)
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
0b83526c-4eee-4ebb-917d-2c3598b119df
Public Version Date
April 22, 2022
Public Version Number
3
DI Record Publish Date
September 20, 2018
Package DI Number
20884521540641
Quantity per Package
10
Contains DI Package
10884521540644
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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 89 |