VersaPAP® Positive Airway Pressure Device
GUDID 00762860215054
VersaPAP® Positive Airway Pressure Device with Universal Tubing
Trudell Medical International
In-line CPAP set, non-nebulizing| Primary Device ID | 00762860215054 |
| NIH Device Record Key | 682398ee-b94a-4ff0-b58a-273ce887d8c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VersaPAP® Positive Airway Pressure Device |
| Version Model Number | 121505 |
| Company DUNS | 203298203 |
| Company Name | Trudell Medical International |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00762860215054 [Primary] |
| GS1 | 10762860215051 [Package] Package: [10 Units] In Commercial Distribution |
| GS1 | 20762860215058 [Package] Package: [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173918
FDA Product Code
| BWF | Spirometer, Therapeutic (Incentive) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-13 |
| Device Publish Date | 2019-11-05 |
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| 10762860055534 - AeroEclipse® ONE Breath Actuated Nebulizer Disposable | 2020-08-11 AeroEclipse® ONE Breath Actuated Nebulizer Disposable |
| 10762860105024 - AEROBIKA OPEP Manometer | 2020-04-30 AEROBIKA OPEP Manometer |
Trademark Results [VersaPAP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSAPAP 87885918 5840584 Live/Registered |
Trudell Medical International 2018-04-20 |
 VERSAPAP 87708147 5667414 Live/Registered |
Trudell Medical International, a registered name of an Ontario, Canada partnership comprised of Trudell Partnership Hold 2017-12-05 |
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