Duns Number:092673953
Device Description: Gas Sampling Line 10' PVC, .050" ID x 108" OD M/M Luers w/ 0.8 Micron Filter
Catalog Number
-
Brand Name
Gas Sampling Line
Version/Model Number
0522
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
6e752ee0-1e4f-40e2-a440-1b4312e2692d
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
August 30, 2019
Package DI Number
10709078007832
Quantity per Package
50
Contains DI Package
00709078007835
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 |