Invacare® Platinum® 5NXG Oxygen Concentrator P5NXG1
GUDID 00841447112075
ASM, FINAL PLATINUM 5NXG NA
INVACARE CORPORATION
Mobile/portable oxygen concentrator| Primary Device ID | 00841447112075 |
| NIH Device Record Key | cb689df1-c57a-42e8-9e47-4fb6b26aec60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invacare® Platinum® 5NXG Oxygen Concentrator |
| Version Model Number | P5NXG1 |
| Catalog Number | P5NXG1 |
| Company DUNS | 076916246 |
| Company Name | INVACARE CORPORATION |
| 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 | false |
| Serial Number | true |
| 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 |
Customer Support Contacts
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com | |
| Phone | +1(440)329-6000 |
| orders@invacare.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1013 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841447112075 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203210
FDA Product Code
| CAW | Generator, oxygen, portable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-28 |
| Device Publish Date | 2021-06-18 |
Devices Manufactured by INVACARE CORPORATION
| 00841447114901 - ASM, STRAP POSITIONING BUCKLE BUTTON | 2024-08-02 Push Button Seat/Chest Positioning Strap for (20"-22" Seat Width) |
| 00841447114918 - POS STRAP 23-24W HOOK/LOOP | 2024-08-02 Hook & Loop Seat/Chest Positioning Strap (24" Seat Width) |
| 00841447114925 - ADJ REAR ANTI-TIPPER (6) | 2024-08-02 Invacare Adjustable Rear Anti-Tippers for 6" Casters |
| 00841447114932 - IV-OXYGEN HOLDER PACKAGE ASBLY | 2024-08-02 Invacare IV/Oxygen Holder Assembly |
| 00841447114949 - KIT ARMPAD FULL W/2 SCREWS CLR | 2024-08-02 Arm Pad w/ screws, Full-Length (13") |
| 00841447114956 - KIT ARMPAD DESK W/2 SCREWS CLR | 2024-08-02 Arm Pad w/ screws, Desk-Length (9") |
| 00841447114963 - WHEEL LOCK EXTENSIONS 6 IN | 2024-08-02 Invacare 6" Wheel Lock Extensions w/ Bungee Cord |
| 00841447114970 - HEMI SMT ART LGRST COMP FTPLT FOR 16-24W | 2024-08-02 Swing-Away Hemi Smartleg Articulating Legrests, Composite Footplates, Padded Calf Pads |
Trademark Results [Invacare]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INVACARE 78172572 2840082 Live/Registered |
Invacare Corporation 2002-10-09 |
 INVACARE 73315171 1243496 Live/Registered |
Invacare Corporation 1981-06-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.