Sleepware G3

GUDID 00606959055735

Sleepware G3

Respironics, Inc.

Polysomnography analyser

• Primary Device ID: 00606959055735
• NIH Device Record Key: 0124e093-738e-4030-a806-872996be6f94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleepware G3
• Version Model Number: Sleepware G3
• Company DUNS: 080728314
• Company Name: Respironics, 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: true
• 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	00606959055735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202142

FDA Product Code

• OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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: 2026-01-30
• Device Publish Date: 2026-01-22

Devices Manufactured by Respironics, Inc.

• 00606959055735 - Sleepware G3: 2026-01-30Sleepware G3
• 00606959055735 - Sleepware G3: 2026-01-30 Sleepware G3
• 00606959060586 - Care Orchestrator: 2026-01-30 Care Orchestrator
• 00606959424852 - DreamStation BiPAP autoSV: 2025-08-12 DreamStation BiPAP autoSV with Humidifier, with Heated Tube, with Cell Modem, Australia
• 00606959424944 - DreamStation BiPAP AVAPS: 2025-08-12 DreamStation BiPAP AVAPS30 AE with Humidifier, with Cell Modem, Australia
• 00606959424951 - DreamStation BiPAP AVAPS: 2025-08-12 DreamStation BiPAP AVAPS30 AE with Cell Modem, Australia
• 00606959424968 - DreamStation BiPAP AVAPS: 2025-08-12 DreamStation BiPAP AVAPS30 AE with Humdifier, with Heated Tube, with Cell Modem, Australia
• 00606959424975 - DreamStation BiPAP AVAPS: 2025-08-12 DreamStation BiPAP AVAPS30 AE with Humidifier with WiFi, Australia
• 00606959424982 - DreamStation BiPAP AVAPS: 2025-08-12 DreamStation BiPAP AVAPS30 AE with WiFi, Australia