Duns Number:008124539
Catalog Number
-
Brand Name
Resp-O2 Endotracheal Tube With Stylette, Uncuffed, 5.0 mm
Version/Model Number
36233
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
K042683,K042683,K042683
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
de0f0769-1aec-4ccc-941c-198f06ead4b3
Public Version Date
May 23, 2022
Public Version Number
1
DI Record Publish Date
May 15, 2022
Package DI Number
00840117312883
Quantity per Package
10
Contains DI Package
00840117317444
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 694 |
2 | A medical device with a moderate to high risk that requires special controls. | 226 |
3 | A medical device with high risk that requires premarket approval | 2 |