Cadwell

GUDID 00840067103913

Ring Electrode with 32in lead attached length

CADWELL INDUSTRIES, INC.

Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium

• Primary Device ID: 00840067103913
• NIH Device Record Key: 589c64d1-6157-4d8c-90c3-9f3c6be5aba3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cadwell
• Version Model Number: 302295-000-032
• 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: true
• 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: false
• 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

Device Dimensions

• Length: 32 Inch
• Length: 32 Inch
• Length: 32 Inch
• Length: 32 Inch
• Length: 32 Inch
• Length: 32 Inch
• Length: 32 Inch
• Length: 32 Inch
• Length: 32 Inch
• Length: 32 Inch
• Length: 32 Inch
• Length: 32 Inch
• Length: 32 Inch
• Length: 32 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067103906 [Primary]
GS1	00840067103913 [Package]; Contains: 00840067103906; Package: Box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933803

FDA Product Code

• GXY: Electrode, cutaneous

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: 2022-10-03
• Device Publish Date: 2022-09-24

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