Invacare® HomeFill® Oxygen System IOH200
GUDID 00841447100034
INVACARE CORPORATION
Oxygen compressor, home-use Oxygen compressor, home-use Oxygen compressor, home-use Oxygen compressor, home-use Oxygen compressor, home-use Oxygen compressor, home-use Oxygen compressor, home-use Oxygen compressor, home-use Oxygen compressor, home-use Oxygen compressor, home-use Oxygen compressor, home-use Oxygen compressor, home-use Oxygen compressor, home-use| Primary Device ID | 00841447100034 |
| NIH Device Record Key | a8255a5d-1ece-47aa-a3d7-94dfed0b9ef9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invacare® HomeFill® Oxygen System |
| Version Model Number | IOH200 |
| Catalog Number | IOH200 |
| 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 | 440-329-6000 |
| orders@invacare.com | |
| Phone | 440-329-6000 |
| orders@invacare.com | |
| Phone | 440-329-6000 |
| orders@invacare.com | |
| Phone | 440-329-6000 |
| orders@invacare.com | |
| Phone | 440-329-6000 |
| orders@invacare.com | |
| Phone | 440-329-6000 |
| orders@invacare.com | |
| Phone | 440-329-6000 |
| orders@invacare.com | |
| Phone | 440-329-6000 |
| orders@invacare.com | |
| Phone | 440-329-6000 |
| orders@invacare.com | |
| Phone | 440-329-6000 |
| orders@invacare.com | |
| Phone | 440-329-6000 |
| orders@invacare.com | |
| Phone | 440-329-6000 |
| orders@invacare.com | |
| Phone | 440-329-6000 |
| orders@invacare.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841447100034 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003939
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 | 5 |
| Public Version Date | 2019-04-22 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [Invacare® HomeFill® Oxygen System]
| 00841447100270 | HF2POSTD81 |
| 00841447100256 | HF2PCL4 |
| 00841447100195 | IOH200C |
| 00841447100164 | IOH2MD |
| 00841447100140 | HF2PC9 |
| 00841447100133 | HF2PCL6 |
| 00841447100126 | HF2POSTD |
| 00841447100119 | HF2POST9 |
| 00841447100096 | HF2POST6 |
| 00841447100034 | IOH200 |
| 00841447100263 | HF2PCM2KIT |
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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