Duns Number:961027315
Device Description: LVMC PAIN TRAY
Catalog Number
34-3511A
Brand Name
CARDINAL HEALTH
Version/Model Number
34-3511A
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
OFQ
Product Code Name
Anesthesia kit
Public Device Record Key
17c5db70-814c-494f-b0de-9dd24f0fe3b3
Public Version Date
July 23, 2018
Public Version Number
2
DI Record Publish Date
May 11, 2018
Package DI Number
50887488953692
Quantity per Package
20
Contains DI Package
10887488953694
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 |