Duns Number:825673239
Device Description: Oxygen tubingnon-sterile,Sauerstoff-Sicherheits-Schlauch,unsteril
Catalog Number
622550
Brand Name
Amsino®Oxygen tubing
Version/Model Number
1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
394e45a5-a3f9-49fd-8ac3-88a7f0dfa266
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
October 22, 2021
Package DI Number
40704411014165
Quantity per Package
50
Contains DI Package
10704411014164
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 | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |