Transcend 503105

GUDID M9505031050

SOMNETICS INTERNATIONAL, INC.

Home CPAP unit

• Primary Device ID: M9505031050
• NIH Device Record Key: 41e70290-cfbf-4e81-b03f-469995480c74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transcend
• Version Model Number: 3 miniCPAP Auto Service Unit
• Catalog Number: 503105
• Company DUNS: 047069263
• Company Name: SOMNETICS INTERNATIONAL, 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 8776219626
• Email: info@somnetics.com

Device Dimensions

• Height: 94 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9505031050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132127

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

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: 2019-04-17
• Device Publish Date: 2019-04-09

On-Brand Devices [Transcend]

• M9505031090: Filter Assembly
• M9505031070: 3 miniCPAP Service Unit
• M9505031060: 3 miniCPAP System
• M9505031050: 3 miniCPAP Auto Service Unit
• M9505031040: 3 miniCPAP Auto System
• M9505031020: 365 miniCPAP System
• M9505031010: 365 miniCPAP Service Unit
• M9505030290: Mobile Power Adapter
• M9505030840: 3 miniCPAP TranSync Bluetooth Module
• M950505030: AirMist Starter Pack
• M950505029: WhisperSoft Micro 6
• M950505028: WhisperSoft Micro 4
• M950505027: AirFlex Micro 4
• M950505026: WhisperSoft Micro 6
• M950505025: WhisperSoft Micro 4
• M950505016: AirMist Cartridges 12
• M950505015: AirMist Cartridges 8
• M950505014: AirMist Cartridges 4
• M950505009: AirMist
• M950505004: AirFlex Micro 6
• M950505003: WhisperSoft Micro
• M950505002: WhisperSoft
• M950503124: WhisperSoft 6
• M950503123: WhisperSoft 4
• M950503122: WhisperSoft 6
• M950503121: WhisperSoft 4
• M950503120: AirFlex 6
• M950503119: AirFlex 4
• M9505030980: P10 Battery
• M9505030260: P4 Battery
• M9505030230: P8 Battery
• M9505050330: Micro WhisperSoft Muffler - C
• M9505050170: Micro PureFresh
• M9505050010: Micro PowerAway Battery