NxtGen Infant Transport Incubator 732-0000

GUDID 00850018561013

Infant Transport Incubator

INTERNATIONAL BIOMEDICAL, LTD.

Transport infant incubator

• Primary Device ID: 00850018561013
• NIH Device Record Key: 13b1eac7-e23c-4ece-9127-bf8086d36b4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NxtGen Infant Transport Incubator
• Version Model Number: NxtGen
• Catalog Number: 732-0000
• Company DUNS: 073179368
• Company Name: INTERNATIONAL BIOMEDICAL, LTD.
• Device Count: 1
• DM Exempt: true
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018561013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220742

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: 2022-11-04
• Device Publish Date: 2022-10-27

On-Brand Devices [NxtGen Infant Transport Incubator]

• 00850018561013: Infant Transport Incubator
• 00850018561020: Infant Transport Incubator