Duns Number:169911828
Device Description: 15' Oxygen White Straight Hose with British Probe DISS Male Connector
Catalog Number
R130P14
Brand Name
Straight Hose
Version/Model Number
15' Oxygen
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
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
d99d6a2a-8e3e-4d6b-bcd6-1d33b9d73698
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
October 22, 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 | 280 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |