Babyleo TN500

GUDID 04048675641308

Drägerwerk AG & Co. KGaA

Conventional infant incubator

• Primary Device ID: 04048675641308
• NIH Device Record Key: 1bb5bd95-fce1-4c21-9a20-064dc57ffae1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Babyleo TN500
• Version Model Number: 2M61100
• 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	04048675641308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251619

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: 2026-03-31
• Device Publish Date: 2026-03-23

On-Brand Devices [Babyleo TN500]

• 04048675000051: 2M60000
• 04048675436607: 2M60000
• 04048675641308: 2M61100