Duns Number:198013435
Device Description: ET Tube Holder (12)00812594010118 Endotracheal Tube Holder Qty. 200812594010064 Endotrache ET Tube Holder (12)00812594010118 Endotracheal Tube Holder Qty. 200812594010064 Endotracheal Tube Holder Qty. 200812594010040 Endotracheal Tube Holder Qty. 200812594010071 Endotracheal Tube Holder Qty. 200812594011115 Endotracheal Tube Holder Qty. 200812594010057 Endotracheal Tube Holder Qty. 2
Catalog Number
N719N
Brand Name
NeoBar NeoNatal Assorted
Version/Model Number
00812594011849
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"
Yes
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
CBH
Product Code Name
Device, Fixation, Tracheal Tube
Public Device Record Key
86a49b60-8d5d-4dc8-b093-1213e14d3972
Public Version Date
July 26, 2022
Public Version Number
3
DI Record Publish Date
June 02, 2021
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 | 153 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |