PleuraFlow® System
GUDID 00856449006031
PF-32 PleuraFlow® System
ClearFlow
Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable| Primary Device ID | 00856449006031 |
| NIH Device Record Key | 93cba999-08d6-4d01-99a2-a0be467623b6 |
| Commercial Distribution Discontinuation | 2018-12-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PleuraFlow® System |
| Version Model Number | PF-32 |
| 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 | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 French |
| Catheter Gauge | 32 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 | 00856449006031 [Primary] |
| GS1 | 10856449006038 [Package] Package: Inner Pack [10 Units] Discontinued: 2018-12-21 Not in Commercial Distribution |
| GS1 | 20856449006035 [Package] Contains: 10856449006038 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 |
[00856449006031]
Ethylene Oxide
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Ethylene Oxide
[00856449006031]
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[00856449006031]
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[00856449006031]
Ethylene Oxide
[00856449006031]
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[00856449006031]
Ethylene Oxide
[00856449006031]
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[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
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[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
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[00856449006031]
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[00856449006031]
Ethylene Oxide
[00856449006031]
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[00856449006031]
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[00856449006031]
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[00856449006031]
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[00856449006031]
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[00856449006031]
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[00856449006031]
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[00856449006031]
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[00856449006031]
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[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
Ethylene Oxide
[00856449006031]
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 |
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