DreamMapper Web (EMEA) 1128262

GUDID 00606959053519

DreamMapper Web EMEA Instance v 2.16

Respironics, Inc.

Self-care monitoring/reporting software

• Primary Device ID: 00606959053519
• NIH Device Record Key: 8592ec9d-dc80-437f-a1fb-adced18acefe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamMapper Web (EMEA)
• Version Model Number: 2.16
• Catalog Number: 1128262
• 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	00606959053519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152356

FDA Product Code

• MNT: Ventilator, continuous, minimal ventilatory support, facility use

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: 2020-05-28
• Device Publish Date: 2020-05-20

On-Brand Devices [DreamMapper Web (EMEA)]

• 00606959051263: DreamMapper Web EU Instance v 2.13
• 00606959048515: DreamMapper Web (EMEA)
• 00606959042001: DreamMapper Web (EMEA)
• 00606959049864: DreamMapper Web EU Instance v 2.11
• 00606959054851: DreamMapper Web EU Instance, Version 2.18
• 00606959053519: DreamMapper Web EMEA Instance v 2.16
• 00606959049031: DreamMapper Web EU Instance v 2.10