Infinity M300+

GUDID 04049098095730

DRAEGER MEDICAL SYSTEMS, INC.

Centralized patient monitor

• Primary Device ID: 04049098095730
• NIH Device Record Key: 9cf88a4b-ba29-4750-9c99-72b5ecc5c4e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity M300+
• Version Model Number: MS33950
• Company DUNS: 788289952
• Company Name: DRAEGER MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049098095730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231477

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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: 2025-02-27
• Device Publish Date: 2025-02-19

Devices Manufactured by DRAEGER MEDICAL SYSTEMS, INC.

• 04048675673408 - Gateway Software Server VF9.0.1: 2025-02-27
• 04048675762256 - Gateway Software Server VF9.1.1: 2025-02-27
• 04048675777762 - Gateway Software Server VF9.1.2: 2025-02-27
• 04048675780212 - Infinity R50-S Recorder: 2025-02-27
• 04049098001519 - Infinity M300 Bedside Charger: 2025-02-27
• 04049098007061 - Infinity Gateway USB Dongle: 2025-02-27
• 04049098095730 - Infinity M300+: 2025-02-27
• 04049098095730 - Infinity M300+: 2025-02-27
• 04049098095778 - SHIP UNIT M300+: 2025-02-27