Duns Number:324869601
Device Description: n.a.
Catalog Number
-
Brand Name
Catheter Mount Tubing; with right angled swivel connector with bronchoscope/suct
Version/Model Number
65-50-130
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
-
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
BZO
Product Code Name
Set, Tubing And Support, Ventilator (W Harness)
Public Device Record Key
9adeafc3-29c8-4610-891e-048b27f1e672
Public Version Date
November 22, 2021
Public Version Number
2
DI Record Publish Date
September 18, 2020
Package DI Number
24250105628795
Quantity per Package
10
Contains DI Package
14250105628798
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 | 334 |
2 | A medical device with a moderate to high risk that requires special controls. | 14 |