Duns Number:484942081
Device Description: Tube holder twin, Consisting of: Polyamide tube holder for double tubes Ø 15-27 mm
Catalog Number
5.428-02
Brand Name
FISSO
Version/Model Number
5.428-02-VE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 04, 2022
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)
-
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
b4defea7-e082-40aa-a38f-bdbda480d51e
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
October 30, 2021
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 | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |