Disp. humi.chamber f.F&P MR850

GUDID 04048675422464

Drägerwerk AG & Co. KGaA

Ventilator breathing circuit, single-use

• Primary Device ID: 04048675422464
• NIH Device Record Key: 089408fa-2c29-406a-87a1-f156a56dff2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disp. humi.chamber f.F&P MR850
• Version Model Number: MP00234
• Company DUNS: 315578914
• Company Name: Drägerwerk AG & Co. KGaA
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675422464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102618

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-06-18

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