DreamMapper iOS China Instance 1136968

GUDID 00606959051362

DreamMapper iOS China Instance v 2.13

Respironics, Inc.

Self-care monitoring/reporting software

• Primary Device ID: 00606959051362
• NIH Device Record Key: f04cf7aa-7dca-4c49-a897-e66a112c7d5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamMapper iOS China Instance
• Version Model Number: 2.13
• Catalog Number: 1136968
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00606959051362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152356

FDA Product Code

• MNS: Ventilator, continuous, non-life-supporting

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: 2020-10-26
• Device Publish Date: 2020-10-16

Devices Manufactured by Respironics, Inc.

• 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
• 00606959424999 - DreamStation BiPAP AVAPS: 2025-08-12 DreamStation BiPAP AVAPS30 AE with Humidifier, with Heated Tube, with WiFi, Australia
• 00606959425378 - DreamStation: 2025-08-12 DreamStation BiPAP AVAPS 30 AAM with Humidifier and Heated Tube, no Bluetooth, China