Duns Number:961027315
Device Description: Anesthesia Breathing Circuit, Peds Circuit, 108IN Expandable TBG
Catalog Number
WCALCEX108
Brand Name
CARDINAL HEALTH
Version/Model Number
WCALCEX108
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 31, 2021
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
K922492,K922492
Product Code
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
90830169-df58-475d-9e65-d3d7f0302e02
Public Version Date
February 01, 2021
Public Version Number
7
DI Record Publish Date
September 14, 2016
Package DI Number
50885380068117
Quantity per Package
20
Contains DI Package
10885380068119
Package Discontinue Date
January 31, 2021
Package Status
Not 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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |