PRO-FLOW 1097344
GUDID 30606959032379
PRO-FLOW NASAL CANNULA, M-F, 0.45x0.40, SINGLE
Respironics, Inc.
Polysomnograph| Primary Device ID | 30606959032379 |
| NIH Device Record Key | e5f7c212-0ef3-4329-822c-a13f1874e227 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRO-FLOW |
| Version Model Number | PRO-FLOW |
| Catalog Number | 1097344 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959032378 [Primary] |
| GS1 | 30606959032379 [Package] Contains: 00606959032378 Package: Multipack [10 Units] Discontinued: 1999-12-31 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K040595
FDA Product Code
| OLV | Standard polysomnograph with electroencephalograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2016-10-05 |
Devices Manufactured by Respironics, Inc.
| 00606959054639 - NightBalance | 2024-12-19 NightBalance Sleep Position Trainer System, Germany |
| 00606959051942 - Trilogy Evo | 2022-05-23 Trilogy Evo, USA |
| 00606959417540 - DreamStation | 2022-01-10 Micro-Flexible Heated 12mm Tube |
| 00606959060135 - Therapy Mask 3100 | 2021-12-16 Medium Wide, Therapy Mask 3100 Silicone |
| 00606959060098 - Therapy Mask 3100 | 2021-11-04 |
| 00606959060104 - Therapy Mask 3100 | 2021-11-04 |
| 00606959060128 - Therapy Mask 3100 | 2021-11-04 |
| 00606959063082 - DreamStation 2 | 2021-11-04 |
Trademark Results [PRO-FLOW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRO-FLOW 90259094 not registered Live/Pending |
The AMES Companies, Inc. 2020-10-16 |
 PRO-FLOW 76545649 not registered Dead/Abandoned |
Burba, Thomas R. 2003-09-22 |
 PRO-FLOW 75248323 2146230 Live/Registered |
Protectoseal Company, The 1997-02-26 |
 PRO-FLOW 74204492 not registered Dead/Abandoned |
Protectoseal Company, The 1991-09-17 |
 PRO-FLOW 73760780 1537897 Dead/Cancelled |
INTERSTATE DRUG EXCHANGE 1988-10-31 |
 PRO-FLOW 73242664 1200440 Dead/Cancelled |
Protex Industries, Inc. 1979-12-13 |
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