Voyager Infant Transport Incubator

GUDID 00868406000020

Voyager Infant Transport Incubator, with Optional PulseOx

INTERNATIONAL BIOMEDICAL, LTD.

Transport infant incubator

• Primary Device ID: 00868406000020
• NIH Device Record Key: d7aada15-ab67-4b66-9840-b02fc0bce8e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Voyager Infant Transport Incubator
• Version Model Number: Voyager
• 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: 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: 5128730033
• Email: sales@int-bio.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868406000020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103524

FDA Product Code

• FPL: Incubator, Neonatal Transport

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-27

On-Brand Devices [Voyager Infant Transport Incubator]

• 00868406000020: Voyager Infant Transport Incubator, with Optional PulseOx
• 00865648000320: Voyager Infant Transport Incubator