AccuSnore

GUDID 10817377022934

AccuSnore Sensor, Disposable, Large

DYMEDIX DIAGNOSTICS, INC.

Polysomnograph

• Primary Device ID: 10817377022934
• NIH Device Record Key: 6878f8b6-867a-4412-a8ab-638f4579f9ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuSnore
• Version Model Number: 10-21100-0601
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817377022937 [Primary]
GS1	10817377022934 [Package]; Contains: 00817377022937; Package: [10 Units]; In Commercial Distribution
GS1	20817377022931 [Package]; Contains: 00817377022937; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990321

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: 2021-07-09
• Device Publish Date: 2021-07-01

Devices Manufactured by DYMEDIX DIAGNOSTICS, INC.

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• 00817377021862 - Perfect Fit: 2021-07-29 Perfect Fit II Adult Effort Belt Sensor, Abdomen, NOX-T3
• 00817377022494 - Perfect Fit: 2021-07-29 Perfect Fit™ 3D Effort Belt Strap, 10 yard roll
• 00817377022500 - SnuggleFit: 2021-07-29 SnuggleFit Effort Belt Strap, 10 yard roll
• 00817377022517 - SnuggleFit: 2021-07-29 SnuggleFit Effort Belt Roll, 50 yard roll
• 00817377022531 - SnuggleFit: 2021-07-29 SnuggleFit Infant Effort Belt - Universal
• 00817377022548 - SnuggleFit: 2021-07-29 SnuggleFit Infant Effort Belt - Alice 5
• 00817377022555 - SnuggleFit: 2021-07-29 SnuggleFit Infant Effort Belt - Embla