Aviator Transport Incubator

GUDID 00865648000306

Aviator Transport Incubator

INTERNATIONAL BIOMEDICAL, LTD.

Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator Transport infant incubator

• Primary Device ID: 00865648000306
• NIH Device Record Key: 19a1536d-8e37-443a-843b-3b6478a6ec79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aviator Transport Incubator
• Version Model Number: Aviator
• 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
• 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	00865648000306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081399

FDA Product Code

• FPL: Incubator, Neonatal Transport

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

On-Brand Devices [Aviator Transport Incubator]

• 00868406000006: Aviator Transport Incubator, with Optional PulseOx
• 00865648000306: Aviator Transport Incubator