Heliox Servo adapter kit

GUDID 07325710012185

Maquet Critical Care AB

Neonatal intensive-care ventilator

• Primary Device ID: 07325710012185
• NIH Device Record Key: e809aec8-2ee0-46d6-9727-c2e2d73f43b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heliox Servo adapter kit
• Version Model Number: 6889487
• Company DUNS: 632707092
• Company Name: Maquet Critical Care AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07325710012185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201874

FDA Product Code

• CBK: Ventilator, Continuous, 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: 2021-06-28
• Device Publish Date: 2021-06-18

Devices Manufactured by Maquet Critical Care AB

• 07325710012673 - Drawer for Low mobile carts: 2023-12-18
• 07325710001653 - Compressor Mini 115V 60Hz: 2023-09-29
• 07325710015117 - Servo-air Lite: 2023-09-29
• 07325710010518 - Base Unit Servo-u MR: 2021-12-09
• 07325710012185 - Heliox Servo adapter kit: 2021-06-28
• 07325710012185 - Heliox Servo adapter kit: 2021-06-28
• 07325710001189 - Air inlet filter: 2020-09-24
• 07325710003114 - Base unit, Servo-air: 2020-09-24
• 07325710003909 - Battery module: 2020-09-24