Caleo

GUDID 04048675240341

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

• Primary Device ID: 04048675240341
• NIH Device Record Key: 99c37a3a-d12d-4f1e-8bb4-7312486842ae
• Commercial Distribution Discontinuation: 2017-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Caleo
• Version Model Number: 2M50000
• 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

Customer Support Contacts

• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675017165 [Primary]
GS1	04048675240341 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003067

FDA Product Code

• FMZ: Incubator, Neonatal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-07-25
• Device Publish Date: 2015-10-24

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• 04048675556183 - Atlan A350 XL: 2023-09-29
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• 04048675697718 - SelfTestLung: 2023-09-07
• 04048675389583 - VentStar humidifier chamber (N): 2023-07-31
• 04048675411758 - VentStar Helix heated (N) Plus: 2023-07-31