Duns Number:003530786
Device Description: Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using m Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
Catalog Number
90151
Brand Name
GAS SAMPLING LINE 120'x.050'x.108' M/F
Version/Model Number
90151
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
-
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
4e0a8d91-6ef4-4379-a2da-46ced8538e9d
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
June 30, 2022
Package DI Number
10859290006301
Quantity per Package
50
Contains DI Package
00859290006304
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |