| Primary Device ID | 00606959021457 |
| NIH Device Record Key | d49381f4-e23e-4455-addd-21be36114b81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Actiware Software |
| Version Model Number | 6.0 |
| Catalog Number | 1104775 |
| Company DUNS | 080728314 |
| Company Name | Respironics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com | |
| Phone | +1(724)744-2500 |
| respironics.service@philips.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959021457 [Primary] |
| IKK | SYSTEM, ISOKINETIC TESTING AND EVALUATION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2016-09-02 |
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