Cadwell

GUDID 00840067103180

RIPmate™ Belt, Pediatric

CADWELL INDUSTRIES, INC.

Home-use sleep apnoea recording system

• Primary Device ID: 00840067103180
• NIH Device Record Key: 232da9a2-a466-400c-8428-ca9a9b4ff1a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cadwell
• Version Model Number: 302521-200-0200
• 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
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067103180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903300

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