INFINITY MASIMO SET MOUNT KIT

GUDID 04049098058100

DRAEGER MEDICAL SYSTEMS, INC.

Patient monitoring system module, pulse oximetry

• Primary Device ID: 04049098058100
• NIH Device Record Key: 2dd8e4af-795f-4188-a015-1f92344671cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITY MASIMO SET MOUNT KIT
• Version Model Number: MS28964
• Company DUNS: 788289952
• Company Name: DRAEGER MEDICAL SYSTEMS, 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18004372437
• Email: info@draeger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049098058100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113798

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

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
• 04049098095778 - SHIP UNIT M300+: 2025-02-27