DEVICE: FLEX ADVANTAGE (50885380029064)
Device Identifier (DI) Information
FLEX ADVANTAGE
65651-919K
In Commercial Distribution
65651-919K
Cardinal Health 200, LLC
65651-919K
In Commercial Distribution
65651-919K
Cardinal Health 200, LLC
1L Flex Advantage Kit W/9'
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| Yes | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 44942 | Suction system canister liner |
A device made of disposable materials used to cover the inner surface of a suction system reusable canister, for the collection of substances such as blood, bodily fluids, rinsing fluids, body tissue, or gas (e.g., laser plume evacuation) from a site of operation. The device may be soft-walled, or it may have walls of semi-rigid plastic with a dedicated lid. Together with the canister, it can be used singularly, or in a connected series to provide greater capacity. This device should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GCX | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Lumen/Inner Diameter: 0.25 Inch |
| Total Volume: 1000 Milliliter |
| Length: 9 Feet |
Device Record Status
982617b9-944d-4542-893d-c21cb2c54ab4
May 03, 2024
5
June 16, 2016
May 03, 2024
5
June 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
00885380029069
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined