SnuggleFit

GUDID 00817377022555

SnuggleFit Infant Effort Belt - Embla

DYMEDIX DIAGNOSTICS, INC.

Polysomnograph

• Primary Device ID: 00817377022555
• NIH Device Record Key: 475c6b8d-5a0f-40f3-bb30-f22e9a32ef12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SnuggleFit
• Version Model Number: 18-13302-0001
• 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	00817377022555 [Primary]

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 [SnuggleFit]

• 00817377022777: SnuggleFit Infant Effort Belt
• 00817377022722: Interface Cable, SnuggleFit, Chest, Alice 5
• 00817377022715: Interface Cable, SnuggleFit, Abdomen, Alice 5
• 00817377022708: Interface Cable, SnuggleFit, Abdomen, Embla
• 00817377022692: Interface Cable, SnuggleFit, Chest, Embla
• 00817377022685: Interface Cable, SnuggleFit, Chest, Grael
• 00817377022678: Interface Cable, SnuggleFit, Abdomen, Grael
• 00817377022661: Interface Cable, SnuggleFit, Abdomen, Alice 6
• 00817377022654: Interface Cable, SnuggleFit, Chest, Alice 6
• 00817377022647: Interface Cable, SnuggleFit, SUM
• 00817377022630: SnuggleFit Effort Interface Kit, Alice 6
• 00817377022623: SnuggleFit Effort Interface Kit, Grael
• 00817377022616: SnuggleFit Effort Interface Kit, Embla
• 00817377022609: SnuggleFit Effort Interface Kit, Alice 5
• 00817377022593: SnuggleFit Effort Interface Kit, Universal
• 00817377022807: SnuggleFit Comfort Wrap (10pk)
• 00817377022586: SnuggleFit Infant Effort Belt - SUM
• 00817377022579: SnuggleFit Infant Effort Belt - Grael
• 00817377022562: SnuggleFit Infant Effort Belt - Alice 6
• 00817377022555: SnuggleFit Infant Effort Belt - Embla
• 00817377022548: SnuggleFit Infant Effort Belt - Alice 5
• 00817377022531: SnuggleFit Infant Effort Belt - Universal
• 00817377022517: SnuggleFit Effort Belt Roll, 50 yard roll
• 00817377022500: SnuggleFit Effort Belt Strap, 10 yard roll