Duns Number:830432451
Device Description: Vital Signs® Gas Sampling Interface
Catalog Number
5640CEI
Brand Name
Vital Signs
Version/Model Number
5640CEI
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
d89729c4-e142-4696-9963-64a13d77d32a
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
50885403294400
Quantity per Package
20
Contains DI Package
10885403294402
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |
| 3 | A medical device with high risk that requires premarket approval | 29 |