Duns Number:879144426
Device Description: Convenient kit for the controlled and accurate mixing and dispensing of gases. Includes 3 Convenient kit for the controlled and accurate mixing and dispensing of gases. Includes 3-way stopcock for drawing of gas or air, 0.2 micron filters provide for sterilization of gas and/or air, and 60cc syringe pre-marked with mixture percentages to eliminate guesswork during prepping. Sterile, single use.
Catalog Number
TR9060-61
Brand Name
Universal Gas Mixing Kit
Version/Model Number
9060-61
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K923397,K923397
Product Code
BXX
Product Code Name
Calibrator, Pressure, Gas
Public Device Record Key
f1800652-bfbd-4501-8ffc-2c712baf177b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 15, 2016
Package DI Number
10853480006157
Quantity per Package
10
Contains DI Package
00853480006150
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |