Babyleo TN500

GUDID 04048675436607

Drägerwerk AG & Co. KGaA

Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator Conventional infant incubator

• Primary Device ID: 04048675436607
• NIH Device Record Key: b2573bc9-3d10-47ff-a23c-acca6b08c177
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Babyleo TN500
• Version Model Number: 2M60000
• Company DUNS: 315578914
• Company Name: Drägerwerk AG & Co. KGaA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675436607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162821

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: 1
• Public Version Date: 2024-03-18
• Device Publish Date: 2024-03-09

On-Brand Devices [Babyleo TN500]

• 04048675000051: 2M60000
• 04048675436607: 2M60000