Duns Number:367919120
Device Description: Vital Signs™ Gas Sampling Line, M/F Luer, Disposable, 3m/10ft
Catalog Number
73325-HEL
Brand Name
Vital Signs™
Version/Model Number
73325-HEL
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
CCK
Product Code Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Public Device Record Key
17c1106d-abf5-4217-b192-a975b66c2470
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
July 13, 2017
Package DI Number
70885403249008
Quantity per Package
10
Contains DI Package
10885403249006
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PAK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 363 |