Duns Number:961027315
Device Description: Suction Catheter; Straight Packed 12 Fr
Catalog Number
ZRSC12
Brand Name
CARDINAL HEALTH ESSENTIALS
Version/Model Number
ZRSC12
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
BSY
Product Code Name
CATHETERS, SUCTION, TRACHEOBRONCHIAL
Public Device Record Key
f29799c9-6fc1-49db-9fa4-bf86ea029ae6
Public Version Date
April 20, 2020
Public Version Number
2
DI Record Publish Date
May 14, 2019
Package DI Number
00888499010188
Quantity per Package
50
Contains DI Package
00888499008208
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |