Duns Number:961027315
Device Description: PAIN MANAGEMENT KIT
Catalog Number
34-7831A
Brand Name
CARDINAL HEALTH
Version/Model Number
34-7831A
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
8cfac2da-5913-4460-8987-38904f386aae
Public Version Date
March 01, 2021
Public Version Number
1
DI Record Publish Date
February 19, 2021
Package DI Number
50888439980590
Quantity per Package
5
Contains DI Package
10888439980592
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 |