Duns Number:080456871
Device Description: Gas Sampling Line, Disposable, Multipatient 2 m/7 ft
Catalog Number
M1145069
Brand Name
Vital Signs™
Version/Model Number
M1145069
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCL
Product Code Name
ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
Public Device Record Key
0f0c9dd5-a445-477a-b2f4-3dd9ca9e90c3
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
March 05, 2021
Package DI Number
50190752143775
Quantity per Package
10
Contains DI Package
10190752143777
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 | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |