ApneaTrak
GUDID 00840067102503
ApneaTrak
CADWELL INDUSTRIES, INC.
Polysomnograph| Primary Device ID | 00840067102503 |
| NIH Device Record Key | 551266d2-dada-4885-9472-246d280de36b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ApneaTrak |
| Version Model Number | 190306-200 |
| Company DUNS | 098554157 |
| Company Name | CADWELL INDUSTRIES, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(509)735-6481 |
| applications@cadwell.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840067102503 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192624
FDA Product Code
| GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE |
| MNR | Ventilatory effort recorder |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-31 |
| Device Publish Date | 2019-04-15 |
Devices Manufactured by CADWELL INDUSTRIES, INC.
| 00840067102879 - Cadwell Guiardian | 2024-03-12 Power Comm |
| 00840067102886 - Cadwell Guiardian | 2024-03-12 Base |
| 00840067102893 - Cadwell Guiardian | 2024-03-12 24-Channel Omni Amplifier |
| 00840067102909 - Cadwell Guiardian | 2024-03-12 ES-10 Electrical Stimulator |
| 00840067102916 - Cadwell Guiardian | 2024-03-12 SMX-32 Direct Cortical Mapping |
| 00840067103609 - Cadwell Guiardian | 2024-03-12 AVX Auditory and Visual Stimulator |
| 10840067101411 - Cadwell Disposable Disc Electrodes | 2024-01-09 |
| 00840067103890 - Cadwell | 2022-10-03 Ring Electrode with 20in lead attached length |
Trademark Results [ApneaTrak]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APNEATRAK 87589907 5932552 Live/Registered |
Cadwell Industries, Inc. 2017-08-30 |
 APNEATRAK 85164016 4021821 Dead/Cancelled |
Cadwell Industries, Inc. 2010-10-28 |
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