Servo duo guard 1pcs

GUDID 17325710004576

Maquet Critical Care AB

Heat/moisture exchanger/microbial filter, non-sterile

• Primary Device ID: 17325710004576
• NIH Device Record Key: b62c5c56-a5a1-4b77-b07f-06214d40f76b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Servo duo guard 1pcs
• Version Model Number: 6884725
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	07325710004579 [Primary]
GS1	17325710004576 [Package]; Contains: 07325710004579; Package: [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030071

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2018-10-10
• Device Publish Date: 2015-11-27

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