| Primary Device ID | 40606959032352 |
| NIH Device Record Key | 45600775-042e-4478-afd2-135797d4cd4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pro-Teh |
| Version Model Number | PRO-FLOW |
| Catalog Number | 1097346 |
| Company DUNS | 080728314 |
| Company Name | Respironics, Inc. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00606959032354 [Primary] |
| GS1 | 30606959032355 [Package] Contains: 00606959032354 Package: Multipack [60 Units] Discontinued: 1999-12-31 Not in Commercial Distribution |
| GS1 | 40606959032352 [Package] Contains: 00606959032354 Package: Multipack [10 Units] Discontinued: 1999-12-31 Not in Commercial Distribution |
| OLV | Standard polysomnograph with electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2016-10-05 |
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| 00606959060098 - Therapy Mask 3100 | 2021-11-04 |
| 00606959060104 - Therapy Mask 3100 | 2021-11-04 |
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| 00606959063228 - DreamStation 2 | 2021-11-04 |