Duns Number:092673953
Device Description: Gas Sampling Line, 10' PVC with Filter, .050" ID x .107" OD, Swivel Elbow Luer
Catalog Number
-
Brand Name
Gas Sampling Line With Filter
Version/Model Number
A9250
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
BZO
Product Code Name
Set, Tubing And Support, Ventilator (W Harness)
Public Device Record Key
57f1e20f-2131-4e1f-8976-a91695a5d86b
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
September 25, 2018
Package DI Number
10709078005616
Quantity per Package
25
Contains DI Package
00709078005619
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 |