NeoPod T, Neonatal Transport Humidification System 9400

GUDID 00850018561648

Neonatal Transport Humidification System

INTERNATIONAL BIOMEDICAL, LTD.

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 Heated respiratory humidifier

• Primary Device ID: 00850018561648
• NIH Device Record Key: de023894-433b-461a-b31c-c98a2845d05d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoPod T, Neonatal Transport Humidification System
• Version Model Number: 9400
• Catalog Number: 9400
• Company DUNS: 073179368
• Company Name: INTERNATIONAL BIOMEDICAL, LTD.
• 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: true
• 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: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018561648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870173

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

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