Duns Number:504406273
Device Description: Jackson Rees 2.1m (83") Star Lumen Inspiratory Tube (038-02-198GE)
Catalog Number
-
Brand Name
Jackson Rees 2.1m (83") Star Lumen Inspiratory Tube (038-02-198GE)
Version/Model Number
2105488-008
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
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
2a0091eb-9f2a-4749-a10a-94e636698f85
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
June 23, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 715 |
2 | A medical device with a moderate to high risk that requires special controls. | 465 |