| Primary Device ID | 09420012401144 |
| NIH Device Record Key | ac24a08d-81ee-4867-b037-bd0b664d6c8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fisher & Paykel Healthcare |
| Version Model Number | 900MR563 |
| Catalog Number | 900MR563 |
| Company DUNS | 590153276 |
| Company Name | FISHER & PAYKEL HEALTHCARE LIMITED |
| Device Count | 1 |
| 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 | true |
| 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 |
| Phone | 1800 446 3908 |
| Customer.CareUSA@fphcare.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09420012401144 [Primary] |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2016-09-08 |
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| 09420012448347 | Sleepstyle Thermosmart Breathing Tube |
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| 09420012433763 | myAIRVO 2 Heated Breathing Tube and Chamber Kit |
| 09420012417480 | Respiratory Humidifier 230V GE/FR/CH |
| 09420012407252 | Respiratory Humidifier MR850 230V NO/SW/FI |
| 09420012427854 | F&P InfoUSB |
| 09420012421524 | SMARTSTICK-5 PACK HC254 |
| 09420012449382 | F&P Vitera Full Face Mask - Medium/ Medium A For Bi-level ventilation |
| 09420012449481 | F&P Vitera Full Face Mask - Large SL For Bi-level ventilation |
| 09420012448460 | F&P Vitera Full Face Mask - Large A For Bi-level ventilation |
| 09420012449191 | F&P Vitera Full Face Mask - Medium A For Bi-level ventilation |
| 09420012449498 | F&P Vitera Full Face Mask - Medium/ Large SL For Bi-level ventilation |
| 09420012403551 | Infant ventilator circuit (0.3 to 4 L/min) single heated |
| 09420012411501 | Infant ventilator circuit (> 4 L/min) single heated |
| 09420012418197 | Infant continuous flow circuit (> 4 L/min) single heated with MR290 autofeed chamber |
| 09420012412065 | Infant continuous flow circuit (> 4 L/min) single heated |
| 09420012424372 | Infant ventilator circuit (0.3 to 4 L/min) dual heated with MR290 autofeed chamber |
| 09420012413253 | Infant ventilator circuit (0.3 to 4 L/min) dual heated with MR290 autofeed chamber |
| 09420012417947 | Infant continuous flow circuit (0.3 to 10 L/min) singleheated with MR290 autofeed chamber and pr |
| 09420012424136 | Optiflow Tubing Kit |
| 09420012412966 | Infant ventilator circuit (> 4 L/min) dual heated with MR290 autofeed chamber |
| 09420012417268 | Adult ventilator circuit Inspiratory heated with MR290 autofeed chamber |
| 09420012403506 | Adult respiratory circuit single heated |
| 09420012403469 | Adult respiratory circuit dual heated |
| 09420012414427 | Adult respiratory circuit single heated |
| 09420012403476 | Adult respiratory circuit dual heated |
| 09420012424716 | Adult ventilator circuit dual heated with Evaqua Technology |
| 09420012414311 | Bi-level/CPAP limb heated with extension and respironics exhalation port |
| 09420012417534 | Adult oxygen therapy circuit heated, with MR290, RT008 and RT022 |
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| 09420012428837 | Dual limb adult circuit kit with Evaqua 2 technology |
| 09420012418067 | Adult ventilator circuit dual heated with MR290 |
| 09420012417862 | Respironics bi-level/CPAP limb heated with MR290 chamber and extension |
| 09420012403582 | Adult breathing circuit inspiratory heated with MR290 autofeed chamber |
| 09420012417244 | Adult ventilator circuit dual heated with MR290 autofeed chamber |
| 09420012414571 | Adult ventilator circuit dual heated with MR290 and RT019 |
| 09420012424365 | Infant ventilator circuit (> 4 L/min) dual heated with MR290 autofeed chamber |
| 09420012424181 | Adult ventilator circuit dual heated with Evaqua Technology |
| 09420012427830 | Tube and Chamber Kit (Junior) |
| 09420012427793 | Heated Breathing Tube |
| 09420012427816 | Tube and Chamber Kit - Airvo2 |
| 09420012427823 | Heated Breathing Tube |
| 09420012425409 | Adult single limb circuit inspiratory heated for use with MR810 only |
| 09420012403148 | Neonatal reusable low flow circuit with Watertrap |
| 09420012403131 | Neonatal reusable bias flow circuit with Watertrap |
| 09420012403117 | Adult reusable circuit 1.5 m with watertrap |