Volu.reflec, incl.Reflector socket

GUDID 07325710001530

Following Device Identifiers are included in this KIT: 07325710004128, 07325710004104

Maquet Critical Care AB

Anaesthesia workstation, general-purpose

• Primary Device ID: 07325710001530
• NIH Device Record Key: 13f49094-b4cb-4275-a44e-dcbf8ab640f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Volu.reflec, incl.Reflector socket
• Version Model Number: 6680327
• Company DUNS: 632707092
• Company Name: Maquet Critical Care AB
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07325710001530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133958

FDA Product Code

• BSZ: Gas-Machine, Anesthesia

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-07
• Device Publish Date: 2015-10-23

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
• 07325710001189 - Air inlet filter: 2020-09-24
• 07325710003114 - Base unit, Servo-air: 2020-09-24
• 07325710003909 - Battery module: 2020-09-24