Cadwell
GUDID 00840067103364
Snore Microphone
CADWELL INDUSTRIES, INC.
Home-use sleep apnoea recording system| Primary Device ID | 00840067103364 |
| NIH Device Record Key | a4e5a37d-92d5-4f60-9721-21170dedf95b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cadwell |
| Version Model Number | 302556-200-9080 |
| Company DUNS | 098554157 |
| Company Name | CADWELL INDUSTRIES, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com | |
| Phone | +1(509)735-6481 |
| applications@cadwell.com |
Device Dimensions
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840067103364 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K941759
FDA Product Code
| BZQ | Monitor, breathing frequency |
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 | 2021-12-23 |
| Device Publish Date | 2021-12-15 |
On-Brand Devices [Cadwell]
| 00840067100783 | Patient Event Switch (25') |
| 00840067100776 | Patient Event Switch (10') |
| 00840067103074 | Patient Event Swtich |
| 00840067103883 | Piezo Velcro Band Kit, Pediatric |
| 00840067103876 | Piezo Loop Kit |
| 00840067103869 | RIPmate Kit Alice 5 |
| 00840067103852 | RIPmate Kit |
| 00840067103845 | RIPmate Kit, Pediatric |
| 00840067103838 | Thermistor Kit |
| 00840067103821 | Piezo Buckle Kit |
| 00840067103814 | Piezo Film Kit |
| 00840067103807 | Piezo Buckle Kit SNAP Labs |
| 00840067103791 | Piezo Buckle Kit Alice 5 |
| 00840067103784 | Velstretch Band Kit |
| 00840067103777 | Velstretch Band Kit, Pediatric |
| 00840067103760 | RIPmate Abdominal Kit Alice 5 |
| 00840067103753 | RIPmate Abdominal Kit |
| 00840067103746 | RIPmate Abdominal Kit, Pediatric |
| 00840067103739 | RIPmate Thoracic Kit Alice 5 |
| 00840067103722 | RIPmate Thoracic Kit |
| 00840067103715 | RIPmate Thoracic Kit, Pediatric |
| 00840067103708 | RIPmate Kit without Processor |
| 00840067103692 | Velstretch Band 1in Buckle |
| 00840067103685 | Velstretch Band Large 1.5in Velcro |
| 00840067103678 | Velstretch Band Medium 1.5in Velcro |
| 00840067103661 | Velstretch Band Small |
| 00840067103654 | Velstretch Band Infant 1in Loop |
| 00840067103647 | RIPmate Disposable Belt Roll |
| 00840067103470 | Pressure Transducer Alice 5 |
| 00840067103449 | Pressure Transducer |
| 00840067103432 | Piezo Snore Sensor |
| 00840067103425 | Piezo Film Sensor |
| 00840067103418 | Piezo Double Loop Sensor |
| 00840067103401 | Piezo Sensor Buckle SNAP Labs |
| 00840067103395 | Piezo Velcro Tab Sensor |
| 00840067103388 | Piezo Buckle Sensor Alice 5 |
| 00840067103371 | Snore Microphone |
| 00840067103364 | Snore Microphone |
| 00840067103357 | Snore Microphone |
| 00840067103340 | Piezo Snore Sensor |
| 00840067103333 | Piezo Snore Sensor |
| 00840067103326 | Interface Cable Disposable Thermal UARS Sensor |
| 00840067103319 | Thermistor Battery Module |
| 00840067103302 | Thermistor Alice 5 |
| 00840067103296 | Thermistor |
| 00840067103289 | Thermocouple |
| 00840067103272 | Thermocouple, Pediatric |
| 00840067103265 | Thermocouple |
| 00840067103258 | CannuTherm® Thermistor |
| 00840067103241 | CannuTherm® Thermocouple |
Trademark Results [Cadwell]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CADWELL 98249019 not registered Live/Pending |
Cadwell Industries, Inc. 2023-10-31 |
 CADWELL 98248985 not registered Live/Pending |
Cadwell Industries, Inc. 2023-10-31 |
 CADWELL 86205220 4644104 Live/Registered |
Cadwell Industries, Inc. 2014-02-26 |
 CADWELL 75541301 2462924 Dead/Cancelled |
Tokyo R&D Co., Ltd. 1998-08-24 |
 CADWELL 73522379 1357871 Live/Registered |
CADWELL LABORATORIES, INC. 1985-02-15 |
 CADWELL 73404427 1290540 Dead/Cancelled |
Cadwell Laboratories, Inc. 1982-12-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.