NeoPod T, Neonatal Transport Humidification System 9400

GUDID 00850018561648

Neonatal Transport Humidification System

INTERNATIONAL BIOMEDICAL, LTD.

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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