Duns Number:961027315
Device Description: CSP MASK, LARGE ADULT SIZE 6
Catalog Number
AMCSPL6
Brand Name
CARDINAL HEALTH
Version/Model Number
AMCSPL6
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 28, 2018
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
BSJ
Product Code Name
MASK, GAS, ANESTHETIC
Public Device Record Key
3b8f935f-7520-4de7-ae3b-8e05502b3b73
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
May 24, 2018
Package DI Number
50885380058873
Quantity per Package
30
Contains DI Package
10885380058875
Package Discontinue Date
May 28, 2018
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 |