Duns Number:049735438
Device Description: Adult Tracheostomy Tube Holder
Catalog Number
ZRTT240
Brand Name
CARDINAL HEALTH ESSENTIALS
Version/Model Number
ZRTT240
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)
-
Over the Counter (OTC)
Yes
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
480f9da8-89d6-4e0b-88d7-23032fe70bdb
Public Version Date
May 17, 2019
Public Version Number
1
DI Record Publish Date
May 09, 2019
Package DI Number
00888499009427
Quantity per Package
10
Contains DI Package
00888499009410
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 | 45 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |
U | Unclassified | 1 |