Duns Number:092673953
Device Description: Gas Sampling Line With Reflective Luer 10' PVC, .038" ID x .107" OD, Swivel Elbow, Reflect Gas Sampling Line With Reflective Luer 10' PVC, .038" ID x .107" OD, Swivel Elbow, Reflective Luer, Gas Sampling Tee for Use In High Humidity Environments
Catalog Number
-
Brand Name
Gas Sampling Line With Reflective Luer
Version/Model Number
0944
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
151d7e49-4f02-49b3-ad96-74be8eb54323
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
June 30, 2019
Package DI Number
10709078007191
Quantity per Package
25
Contains DI Package
00709078007194
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 |