Duns Number:092673953
Device Description: Bracket with Tube Guide
Catalog Number
-
Brand Name
Bracket with Tube Guide
Version/Model Number
WP-7704
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYE
Product Code Name
Attachment, Breathing, Positive End Expiratory Pressure
Public Device Record Key
31a9e01f-f843-4e58-ab20-cf46ab8d3af2
Public Version Date
October 25, 2021
Public Version Number
1
DI Record Publish Date
October 15, 2021
Package DI Number
10709078013574
Quantity per Package
1
Contains DI Package
00709078013560
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 746 |
2 | A medical device with a moderate to high risk that requires special controls. | 320 |