Cadwell BlueBird

GUDID 00840067104156

Rip Belt MED

CADWELL INDUSTRIES, INC.

Polysomnograph

• Primary Device ID: 00840067104156
• NIH Device Record Key: 619b8e25-96e9-48ed-b956-c9dfe4d0b10e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cadwell BlueBird
• Version Model Number: 302501-200-040
• Company DUNS: 098554157
• Company Name: CADWELL INDUSTRIES, INC.
• Device Count: 20
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067104156 [Unit of Use]
GS1	00840067104163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242424

FDA Product Code

• MNR: Ventilatory effort recorder

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: 2026-01-08
• Device Publish Date: 2025-12-31

On-Brand Devices [Cadwell BlueBird]

• 00840067104170: Rip Belt LRG
• 00840067104156: Rip Belt MED
• 00840067104132: Rip Belt SML