PleuraFlow® ZIP
GUDID 00856449006161
The ZIP, Accessory Shuttle for PleuraFlow® System
ClearFlow
Mediastinal drainage catheter Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial Mediastinal drainage catheter, non-antimicrobial| Primary Device ID | 00856449006161 |
| NIH Device Record Key | 646cf8fc-2e12-4851-9518-eb24b3ee419c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PleuraFlow® ZIP |
| Version Model Number | PF-ZIP 1.5 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Special storage condition” as follows: “Handle with care according to institutional protocol. THE ZIP should be stored under good conditions that protect it from extremes of temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856449006161 [Primary] |
FDA Product Code
| OTK | Wound Drain Catheter System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-25 |
| Device Publish Date | 2019-08-09 |
Devices Manufactured by ClearFlow
| 10856449006175 - Pleuraflow® System with FlowGlide | 2021-03-17 PFFG3-20 Pleuraflow® System with FlowGlide |
| 10856449006182 - Pleuraflow® System with FlowGlide | 2021-03-17 PFFG3-24 Pleuraflow® System with FlowGlide |
| 10856449006199 - Pleuraflow® System with FlowGlide | 2021-03-17 PFFG3-28 Pleuraflow® System with FlowGlide |
| 10856449006205 - Pleuraflow® System with FlowGlide | 2021-03-17 PFFG3-32 Pleuraflow® System with FlowGlide |
| 10856449006229 - Pleuraflow® System with FlowGlide | 2021-03-17 PFFG3-20 XDL Pleuraflow® System with FlowGlide |
| 10856449006236 - Pleuraflow® System with FlowGlide | 2021-03-17 PFFG3-24 XDL Pleuraflow® System with FlowGlide |
| 10856449006243 - Pleuraflow® System with FlowGlide | 2021-03-17 PFFG3-24 RA Pleuraflow® System with FlowGlide |
| 10856449006250 - Pleuraflow® System with FlowGlide | 2021-03-17 PFFG3-28 RA 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.