Duns Number:080456871
Device Description: Adult Anesthesia Breathing Circuit
Catalog Number
A4V16XX4T
Brand Name
Vital Signs™
Version/Model Number
A4V16XX4T
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
OFP
Product Code Name
Anesthesia breathing circuit kit (adult & pediatric)
Public Device Record Key
4df7e862-17a0-4e9a-816e-c0ee6fdf0ca6
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
November 08, 2021
Package DI Number
50190752160390
Quantity per Package
20
Contains DI Package
10190752160392
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 | 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 |