Perfect Fit

GUDID 10817377023016

Cadwell FastTrack Effort Belt Sensor, Abdomen

DYMEDIX DIAGNOSTICS, INC.

Polysomnograph

• Primary Device ID: 10817377023016
• NIH Device Record Key: 21491095-5f99-4be3-9be6-57265b4d56f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perfect Fit
• Version Model Number: 11-44200-7501
• Company DUNS: 079976463
• Company Name: DYMEDIX DIAGNOSTICS, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817377023019 [Primary]
GS1	10817377023016 [Package]; Contains: 00817377023019; Package: [10 Units]; In Commercial Distribution
GS1	20817377023013 [Package]; Contains: 00817377023019; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040605

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: 2021-07-29
• Device Publish Date: 2021-07-21

On-Brand Devices [Perfect Fit]

• 00817377022470: Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard roll
• 00817377022463: Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard roll
• 00817377022456: Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard roll
• 00817377022449: Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard roll
• 00817377022401: Interface Cable, FastTrack, SUM
• 00817377022395: FastTrack Effort Interface Kit, Alice6
• 00817377022388: FastTrack Effort Interface Kit, Grael
• 00817377022371: FastTrack Effort Interface Kit, Embla
• 00817377022364: FastTrack Effort Interface Kit, Alice 5
• 00817377022357: FastTrack Starter Kit, Adult, Alice 6
• 00817377022340: FastTrack Starter Kit, Pediatric, Alice 6
• 00817377022333: FastTrack Starter Kit, Adult, Grael
• 00817377022326: FastTrack Starter Kit, Pediatric, Grael
• 00817377022319: FastTrack Starter Kit, Adult, Embla
• 00817377022302: FastTrack Starter Kit, Pediatric, Embla
• 00817377022296: FastTrack Starter Kit, Adult, Alice 5
• 00817377022289: FastTrack Starter Kit, Pediatric, Alice 5
• 00817377022272: FastTrack Starter Kit, Adult, Universal
• 00817377022265: FastTrack Starter Kit, Pediatric, Universal
• 00817377022258: FastTrack Demo Kit, Adult, Alice 6
• 00817377022241: FastTrack Demo Kit, Pediatric, Alice 6
• 00817377022234: FastTrack Demo Kit, Adult, Grael
• 00817377022227: FastTrack Demo Kit, Pediatric, Grael
• 00817377022210: FastTrack Demo Kit, Adult, Embla
• 00817377022203: FastTrack Demo Kit, Pediatric, Embla
• 00817377022197: FastTrack Demo Kit, Adult, Alice 5
• 00817377022180: FastTrack Demo Kit, Pediatric, Alice 5
• 00817377022173: FastTrack Demo Kit, Adult, Universal
• 00817377022166: FastTrack Demo Kit, Pediatric, Universal
• 00817377022111: FastTrack Effort Pack, Adult
• 00817377022104: FastTrack Effort Pack, Pediatric
• 00817377022098: Interface Cable, FastTrack, Chest, Alice 6
• 00817377022081: Interface Cable, FastTrack, Abdomen, Alice 6
• 00817377022074: Interface Cable, FastTrack, Chest, Grael
• 00817377022067: Interface Cable, FastTrack, Abdomen, Grael
• 00817377022050: Interface Cable, FastTrack, Chest, Embla
• 00817377022043: Interface Cable, FastTrack, Abdomen, Embla
• 00817377022036: Interface Cable, FastTrack, Chest, Alice 5
• 00817377022029: Interface Cable, FastTrack, Abdomen, Alice 5
• 00817377022012: FastTrack Effort Interface Kit
• 00817377021947: Interface Cable, Fast Track, Chest
• 00817377021930: Interface Cable, Fast Track, Abdomen
• 00817377021848: Perfect Fit 3D Effort Module, Chest, NOX-T3
• 00817377021831: Perfect Fit 3D Effort Module, Abdomen, NOX-T3
• 00817377021824: Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard roll
• 00817377021817: Perfect Fit™ 3D Effort Belt Sensor, Abdomen, Nomad
• 00817377021800: Perfect Fit™ 3D Effort Belt Sensor, Chest, Nomad
• 00817377021794: Perfect Fit™ 3D Effort Belt Sensor, Chest, Keyhole
• 00817377021787: Perfect Fit™ 3D Effort Belt Sensor, Abdomen, Keyhole
• 00817377021725: Cadwell Sensor Kit, Adult, Disposable