Duns Number:092673953
Device Description: Gas Sampling Line, 10' PVC, .038" ID x .107" OD, Swivel Elbow, Reflective Luer
Catalog Number
-
Brand Name
Gas Sampling Line wit Reflective Luer
Version/Model Number
0937
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
a82c0ec3-4102-4df8-9302-5b1a6c9c3471
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
December 18, 2020
Package DI Number
10709078012409
Quantity per Package
200
Contains DI Package
00709078012402
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |