Duns Number:141668116
Device Description: This kit contains: 1 RES032 Cylinder Wrench, 1 RES012 Tubing Connector, 1 RES018 Tubing Co This kit contains: 1 RES032 Cylinder Wrench, 1 RES012 Tubing Connector, 1 RES018 Tubing Connector with Swivel, 1 RES035 Brass Washer with Rubber Ring, 2 RES003 Oxygen In Use Sign, 2 RES1107 Adult Oxygen Cannula with 7ft Tubing.
Catalog Number
APRO025RESO2KIT
Brand Name
O2 Starter Kit
Version/Model Number
APRO025RESO2KIT
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
Yes
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
-
Product Code Name
-
Public Device Record Key
ce384c26-f141-41c8-bd46-ac791740d99a
Public Version Date
August 31, 2018
Public Version Number
1
DI Record Publish Date
July 31, 2018
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 | 160 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 68 |