Duns Number:368457563
Device Description: Infant/Neonatal Airway Adapter with Dehumidification Tubing for CapnoFlex Module
Catalog Number
2013068-004
Brand Name
Vital Signs™
Version/Model Number
2013068-004
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
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
BZA
Product Code Name
CONNECTOR, AIRWAY (EXTENSION)
Public Device Record Key
d93543f8-d0fc-4558-b587-fd1c39693657
Public Version Date
December 07, 2020
Public Version Number
1
DI Record Publish Date
November 27, 2020
Package DI Number
50190752110685
Quantity per Package
10
Contains DI Package
10190752110687
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |