HUMIDIFIER HOLDER

GUDID 07325710000724

Sales kit containing: 1 pc Humidification holder assembly 07325710004258 1 pc Rail clamp 07325710004265

Maquet Critical Care AB

Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator

• Primary Device ID: 07325710000724
• NIH Device Record Key: cfed6df7-0693-4689-9320-7ff76eb9915f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HUMIDIFIER HOLDER
• Version Model Number: 6693735
• 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: true
• 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	07325710000724 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151814

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

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: 2019-05-28
• Device Publish Date: 2016-02-09

On-Brand Devices [HUMIDIFIER HOLDER]

• 07325710000724: Sales kit containing: 1 pc Humidification holder assembly 07325710004258 1 pc Rail clamp 0732571
• 07325710000410: 6523935