Puritan Bennett
GUDID 10884521670785
D/FLEX FLTR, BARB, 12/CS FILTER, INHALATION, PB-BARB, Disposable
Covidien LP
Heat/moisture exchanger/microbial filter, non-sterile| Primary Device ID | 10884521670785 |
| NIH Device Record Key | a0bedfc8-4351-4ca8-8c80-edfe68c4c272 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Puritan Bennett |
| Version Model Number | 4-074603-00 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 12 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com | |
| Phone | +1(508)261-8000 |
| Covidien.UDI@covidien.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521670785 [Primary] |
| GS1 | 20884521670782 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K934132
FDA Product Code
| CAH | Filter, Bacterial, Breathing-Circuit |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-12-02 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Puritan Bennett]
| 30884521252954 | End Tidal CO2 Monitoring Option For 980 Series Ventilator |
| 10884521101548 | Expiratory Bacterial Filter 840 Ventilator |
| 10884521706989 | Disposable Adult Circuit |
| 10884521706972 | Disposable Pediatric Circuit |
| 30884521617272 | D/Flex Inspiratory Filter Disposable 22mm ISO Conical Inlet / 22mm ISO Conical Outlet (12 PACK), |
| 20884521609102 | Wall Air Water Trap For 980 Series Ventilator |
| 20884521254609 | Oxygen Sensor |
| 20884521252940 | Proximal Flow Monitoring Option For 980 Series Ventilator |
| 10884521148161 | Drain Port Cap Reusable |
| 10884521135079 | Nasal Mask CPAP Interface,Shallow Cushion |
| 10884521134812 | CPAP Interface with Nasal Cushion Assembly,Standard |
| 10884521134782 | Tubing (15 mm) and Swivel Adapter (15 mm / 22 mm) |
| 10884521134720 | CPAP Interface without Nasal Pillows Assembly |
| 10884521134713 | CPAP Interface with Nasal Pillows Assembly,Medium, Large |
| 10884521134706 | Soft Headgear CPAP Interface Circuit Kit,Large, Narrow Shell |
| 10884521134683 | Soft Headgear CPAP Interface Circuit Kit,Large, Standard Shell |
| 10884521134522 | Swivel Adapter |
| 10884521134515 | Narrow Shell Assembly,For Soft Headgear CPAP Interface Circuit |
| 10884521134485 | Narrow CPAP Shell,For Soft Headgear CPAP Interface Circuit |
| 10884521134461 | Narrow Vent Shell,For Soft Headgear CPAP Interface Circuit |
| 10884521134447 | Calibration Shell,For Soft Headgear CPAP Interface Circuit |
| 10884521134416 | Nasal Ventilation Shell,For Soft Headgear CPAP Interface Circuit |
| 10884521134409 | Shell with Pressure Port,For Soft Headgear CPAP Interface Circuit |
| 10884521134386 | Shell with Velcro Patch Assembly,For Soft Headgear CPAP Interface Circuit |
| 10884521134362 | Shell and Thermometer Ports,For Soft Headgear CPAP Interface Circuit |
| 10884521134355 | Flex Tube Assembly,For Soft Headgear CPAP Interface Circuit |
| 10884521134287 | Circuit Assembly,No Pressure |
| 10884521134034 | CPAP Tubing |
| 10884521127104 | Mask with Harness,Small |
| 30884521084029 | Re/X700 Reusable Expiratory Filter |
| 20884521083490 | 4 Hr Battery For 800 Series Ventilator Pole Cart |
| 10884521701328 | D/FLEX FLTR, 22MMISO, BARB 12/C FILTER/, INHALATION,SPU, Disposable |
| 10884522019354 | 800 Series Ventilator System,Model 840 |
| 10884521211230 | 800 Series Ventilator System,Model 840 |
| 10884521211223 | 800 Series Ventilator System,Model 840 |
| 10884521211216 | 800 Series Ventilator System,Model 840 |
| 10884521211209 | 800 Series Ventilator System,Model 840 |
| 10884521211094 | 800 Series Ventilator System,Model 840 |
| 10884521211087 | 800 Series Ventilator System,Model 840 |
| 10884521183568 | 800 Series Ventilator System,Model 840 |
| 10884521183551 | 800 Series Ventilator System,Model 840 |
| 10884521183544 | 800 Series Ventilator System,Model 840 |
| 10884521183520 | 800 Series Ventilator System,Model 840 |
| 10884521183513 | 800 Series Ventilator System,Model 840 |
| 10884521181250 | 800 Series Ventilator System,Model 840 |
| 10884521181021 | 800 Series Ventilator System,Model 840 |
| 10884521181014 | 800 Series Ventilator System,Model 840 |
| 10884521181007 | 800 Series Ventilator System,Model 840 |
| 10884521180994 | 800 Series Ventilator System,Model 840 |
| 10884521077218 | 800 Series Ventilator System,Model 840 |
Trademark Results [Puritan Bennett]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PURITAN BENNETT 77654545 4038907 Live/Registered |
COVIDIEN LP 2009-01-22 |
 PURITAN BENNETT 75786546 2387643 Live/Registered |
COVIDIEN LP 1999-08-27 |
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