Duns Number:141668116
Device Description: Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - Pediatric
Catalog Number
RES030P
Brand Name
Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - Pediatric
Version/Model Number
RES030P
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
b7330bb7-bbf9-471b-ac13-f46f0c4ae890
Public Version Date
August 31, 2018
Public Version Number
1
DI Record Publish Date
July 31, 2018
Package DI Number
10848530062245
Quantity per Package
20
Contains DI Package
00848530062248
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |