TriplePlay

GUDID 00817377021039

FM2 - Embla

DYMEDIX DIAGNOSTICS, INC.

Polysomnograph

• Primary Device ID: 00817377021039
• NIH Device Record Key: a64d6781-5768-4709-bc95-3e7a2c0da7e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriplePlay
• Version Model Number: 12-40201-0001
• 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	00817377021039 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-11

On-Brand Devices [TriplePlay]

• 00817377022432: Interface Cable, Limb Movement
• 00817377022425: Airflow/Snore Dual Sensor
• 00817377022418: AccuSnore, Reusable Sensor
• 00817377021985: Interface Cable, NOX-T3
• 00817377021978: Interface Cable, NOX-T3, LM1 or LM2
• 00817377021961: FM4 - NOX-T3, Universal
• 00817377021954: FM3 - NOX-T3, Universal
• 00817377021923: Interface Cable, Snore, Keyhole
• 00817377021916: Interface Cable, Snore, Universal
• 00817377021909: Interface Cable, Nomad, LM1 or LM2
• 00817377021893: Interface Cable, Nomad, Abd
• 00817377021886: Interface Cable, Nomad, Chest
• 00817377021879: Interface Cable, Nomad, Therm
• 00817377021770: FM4 - Embla-N7000 Bedside Unit
• 00817377021763: FM4 - Embla-N7000 W/Patient Unit
• 00817377021756: FM5 - Embla-N7000 W/Patient Unit
• 00817377021749: FM5 - Embla-N7000 Bedside Unit
• 00817377021732: Adapter, Embla to 1.5mm Connector
• 00817377021213: FM5 - Grael
• 00817377021206: FM5 - Alice 6
• 00817377021190: FM5 - Alice 5
• 00817377021183: FM5 - Embla
• 00817377021176: FM5 - Universal (1.5mm)
• 00817377021169: FM4 - Grael
• 00817377021152: FM4 - Alice 6
• 00817377021145: FM4 - Alice 5
• 00817377021138: FM4 - Embla
• 00817377021121: FM4 - Universal (1.5mm)
• 00817377021114: FM2 - Grael
• 00817377021107: FM2 - Alice 6
• 00817377021091: FM3 - Grael
• 00817377021084: FM3 - Alice 6
• 00817377021077: FM3 - Alice 5
• 00817377021060: FM2 - Alice 5
• 00817377021053: FM3 - Embla
• 00817377021046: FM3 - Universal (1.5mm)
• 00817377021039: FM2 - Embla
• 00817377021022: FM2 - Universal (1.5mm)
• 00817377021015: Interface Cable, Airflow/Snore Dual Sensor
• 00817377021008: EFM, Gemini, DIN
• 00817377020995: Reusable Interface Cable, Snore
• 00817377020988: Interface Cable, Cadwell, Disposable Effort Belt, Abdomen
• 00817377020971: Interface Cable, Cadwell, Disposable Effort Belt, Chest
• 00817377020964: Interface Cable, Perfect Fit Disposable Effort Belt, Alice 5
• 00817377020957: Interface Cable, Perfect Fit Disposable Effort Belt (96")
• 00817377020940: FM1 - Universal (1.5mm)
• 00817377020933: FM1
• 00817377020926: FM1 - SmartRecorder
• 00817377020919: FM1 - Grael
• 00817377020902: FM1 - Alice 6