Isolette® 8000 plus

GUDID 04049098090612

I8000 plus

DRAEGER MEDICAL SYSTEMS, INC.

Conventional infant incubator

• Primary Device ID: 04049098090612
• NIH Device Record Key: 3fd42f2c-db0e-4230-9c23-9fef3fac8679
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolette® 8000 plus
• Version Model Number: MU20602
• Company DUNS: 788289952
• Company Name: DRAEGER MEDICAL SYSTEMS, INC.
• 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: true
• Expiration Date: true
• 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: 18004372437
• Email: info@draeger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049098090612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172154

FDA Product Code

• FMZ: Incubator, Neonatal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-11

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