PleuraFlow® System
GUDID 10856449006021
PF-28 PleuraFlow® System
ClearFlow
Closed-wound drain| Primary Device ID | 10856449006021 |
| NIH Device Record Key | 48275c53-08a8-4f89-a590-4065d87df326 |
| Commercial Distribution Discontinuation | 2018-12-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PleuraFlow® System |
| Version Model Number | PF-28 |
| Company DUNS | 827428223 |
| Company Name | ClearFlow |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
| Catheter Gauge | 28 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. The system should be stored in an area with good ventilation under good conditions that protect it from extremes of temperature and humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856449006024 [Primary] |
| GS1 | 10856449006021 [Package] Contains: 00856449006024 Package: Inner pack [10 Units] Discontinued: 2018-12-21 Not in Commercial Distribution |
| GS1 | 20856449006028 [Package] Package: Case [1 Units] Discontinued: 2018-12-21 Not in Commercial Distribution |
FDA Product Code
| OTK | Wound Drain Catheter System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
[10856449006021]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-25 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [PleuraFlow® System]
| 00856449006031 | PF-32 PleuraFlow® System |
| 10856449006021 | PF-28 PleuraFlow® System |
| 20856449006011 | PF-24 PleuraFlow® System |
| 00856449006000 | PF-20 PleuraFlow® System |
Trademark Results [PleuraFlow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLEURAFLOW 77573217 3944788 Live/Registered |
CLEARFLOW, INC. 2008-09-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.