Duns Number:022721133
Device Description: Oxygen Tubing with 2 standard connectors (6 mm), 25’ (7.6 m)
Catalog Number
SO-1946-0
Brand Name
n/a
Version/Model Number
SO-1946-0
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
-
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
ece473f7-5195-43b4-9106-2bbf0173d671
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
November 30, 2016
Package DI Number
10607411801119
Quantity per Package
25
Contains DI Package
00607411801112
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 | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |