N/A PT101USR

GUDID 10190752102484

N/A

Carefusion Corporation

Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier

• Primary Device ID: 10190752102484
• NIH Device Record Key: 5b4c8851-fadf-4223-847e-31b753bfb767
• Commercial Distribution Discontinuation: 2022-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: N/A
• Version Model Number: PT101USR
• Catalog Number: PT101USR
• Company DUNS: 830432451
• Company Name: Carefusion Corporation
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752102484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131895

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: 4
• Public Version Date: 2024-05-21
• Device Publish Date: 2016-11-04

On-Brand Devices [N/A]

• 10190752102484: N/A
• 10190752102477: N/A
• 10190752102460: N/A