Invacare® USB Dongle, Platinum Mobile
GUDID 00841447100973
INVACARE CORPORATION
Portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator| Primary Device ID | 00841447100973 |
| NIH Device Record Key | fb99d9fa-5b8d-440d-91e6-4a20bef8f7f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invacare® USB Dongle, Platinum Mobile |
| Version Model Number | POC1-CONNECT |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841447100973 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160630
FDA Product Code
| CAW | Generator, oxygen, portable |
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 | 2019-04-22 |
| Device Publish Date | 2017-10-20 |
Devices Manufactured by INVACARE CORPORATION
| 00841447103318 - Invacare® Supply Line Assembly with Coiled Tubing | 2024-04-18 Invacare 1105177 Supply Line Assembly with Coiled Tubing (12') |
| 00841447103325 - Invacare® Barbed Brass Fire Break Connector | 2024-04-18 Invacare 1180107 Connector Barbed Brass Fire Break 9153653435 |
| 00841447103332 - Invacare® HomeFill® Cylinder Bag | 2024-04-18 Invacare HF2PC9BAG Home Fill M9 Cylinder Bag |
| 00841447103349 - Invacare® HomeFill® Cylinder Bag | 2024-04-18 Invacare HF2PCL6BAG Home Fill ML6 Cylinder Bag |
| 00841447103356 - Invacare® HomeFill® Cylinder Bag | 2024-04-18 Invacare HF2POST6BAG Home Fill ML6 Post Valve Cylinder Bag |
| 00841447103363 - Invacare® HomeFill® Cylinder Bag | 2024-04-18 Invacare HF2POST9BAG Home Fill M9 Post Valve Cylinder Bag |
| 00841447103370 - Invacare® Platinum® 10 Oxygen Concentrator | 2024-04-18 Invacare IRC10LXO2 Platinum 10 Oxygen Concentrator |
| 00841447103387 - Invacare® Perfecto2™ V Oxygen Concentrator | 2024-04-18 Invacare IRC5PO2V Perfecto2 V Oxygen Concentrator |
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 |
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