Duns Number:092673953
Device Description: 1 - Packaged 50' O2 Tubing (0052), 6 - Packaged Soft Cannula with 7' Tubing (0556), 1 - Ba 1 - Packaged 50' O2 Tubing (0052), 6 - Packaged Soft Cannula with 7' Tubing (0556), 1 - Barbed Connector (40076), 1 - Cylinder Wrench (20014), 1 - Key Chain (90027), 1 - No Smoking Sign (70816).
Catalog Number
-
Brand Name
Composite Respiratory Kit
Version/Model Number
0767
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
2d7436aa-9a16-4ff6-845f-7cb7296fdb2a
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
April 24, 2017
Package DI Number
10709078003612
Quantity per Package
10
Contains DI Package
00709078003615
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |