Duns Number:008124539
Device Description: Resp-O2 Comfort-Foam Trach Tube Holder, 2 PC, Pediatric, Medium, Maximum Neck Size 18"/46 Resp-O2 Comfort-Foam Trach Tube Holder, 2 PC, Pediatric, Medium, Maximum Neck Size 18"/46 cm
Catalog Number
-
Brand Name
Resp-O2 Comfort-Foam Trach Tube Holder
Version/Model Number
35028
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
CBH
Product Code Name
Device, Fixation, Tracheal Tube
Public Device Record Key
baa8785f-c32a-417e-9efe-5a7b132c5a70
Public Version Date
May 23, 2022
Public Version Number
1
DI Record Publish Date
May 14, 2022
Package DI Number
00840117319103
Quantity per Package
10
Contains DI Package
00840117319264
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 |