Duns Number:961027315
Device Description: Cassette Trumpet Valve w/,Bariatric Probe, Double Spike
Catalog Number
ABP1201
Brand Name
CARDINAL HEALTH
Version/Model Number
ABP1201
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
FQH
Product Code Name
LAVAGE, JET
Public Device Record Key
80430cd6-878b-4c4a-9924-136134a1bfc2
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
July 22, 2016
Package DI Number
50885380107809
Quantity per Package
12
Contains DI Package
10885380107801
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 | 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 |