Duns Number:045975349
Catalog Number
-
Brand Name
TRACH-MATE HOLDER PEDIATRIC
Version/Model Number
08148217
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
a0776344-bff5-49a2-8997-8fd599b1da71
Public Version Date
September 07, 2022
Public Version Number
1
DI Record Publish Date
August 30, 2022
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 | 2022 |