Duns Number:368457563
Device Description: Gas Sampling Line, Multipatient, with Elbow Connector, Disposable, 3m/10ft
Catalog Number
M1145072
Brand Name
Vital Signs™
Version/Model Number
M1145072
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
0b1749b9-6464-4b91-a2dc-12dc5f20e758
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
January 28, 2021
Package DI Number
50190752141610
Quantity per Package
10
Contains DI Package
10190752141612
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 600 |