PleuraFlow® System with FlowGlide
GUDID 20856449006127
PFFG-28 RA PleuraFlow® System with FlowGlide
ClearFlow
Closed-wound drain| Primary Device ID | 20856449006127 |
| NIH Device Record Key | 19284513-24f3-4848-9b7c-adc8d3713f50 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PleuraFlow® System with FlowGlide |
| Version Model Number | PFFG-28 RA |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
| 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 and ultraviolet light. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856449006123 [Primary] |
| GS1 | 10856449006120 [Package] Contains: 00856449006123 Package: Inner Pack [10 Units] In Commercial Distribution |
| GS1 | 20856449006127 [Package] Contains: 10856449006120 Package: Case [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163139
FDA Product Code
| OTK | Wound Drain Catheter System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
[20856449006127]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-25 |
| Device Publish Date | 2019-04-02 |
On-Brand Devices [PleuraFlow® System with FlowGlide]
| 20856449006103 | PFFG-24 XDL PleuraFlow® System with FlowGlide |
| 00856449006093 | PFFG-20 XDL PleuraFlow® System with FlowGlide |
| 20856449006080 | PFFG-32 PleuraFlow® System with FlowGlide™ |
| 20856449006073 | PFFG-28 PleuraFlow® System with FlowGlide™ |
| 20856449006066 | PFFG-24 PleuraFlow® System with FlowGlide™ |
| 20856449006059 | PFFG-20 PleuraFlow® System with FlowGlide™ |
| 10856449006045 | PF-20 SEDL PleuraFlow® System with FlowGlide |
| 20856449006127 | PFFG-28 RA PleuraFlow® System with FlowGlide |
| 00856449006147 | PFFG-32 RA PleuraFlow® System with FlowGlide™ |
| 20856449006110 | PFFG-24 RA PleuraFlow® System with FlowGlide |
| 10856449006267 | PFFG3-32 RA Pleuraflow® System with FlowGlide |
| 10856449006250 | PFFG3-28 RA Pleuraflow® System with FlowGlide |
| 10856449006243 | PFFG3-24 RA Pleuraflow® System with FlowGlide |
| 10856449006236 | PFFG3-24 XDL Pleuraflow® System with FlowGlide |
| 10856449006229 | PFFG3-20 XDL Pleuraflow® System with FlowGlide |
| 10856449006205 | PFFG3-32 Pleuraflow® System with FlowGlide |
| 10856449006199 | PFFG3-28 Pleuraflow® System with FlowGlide |
| 10856449006182 | PFFG3-24 Pleuraflow® System with FlowGlide |
| 10856449006175 | PFFG3-20 Pleuraflow® System with FlowGlide |
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.