| Primary Device ID | 00606959039872 |
| NIH Device Record Key | e33b715d-0f3c-4220-b694-355bddead5c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acitware Software |
| Version Model Number | 6.0 |
| Catalog Number | 1104776 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959039872 [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 | 4 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2016-09-02 |
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