Caleo

GUDID 04048675240341

Drägerwerk AG & Co. KGaA

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

Devices Manufactured by Drägerwerk AG & Co. KGaA

• 04048675564553 - T-piece N for NO-A: 2024-10-16
• 04048675564577 - T-piece N for Nebulization: 2024-10-16
• 04048675715252 - Anesth Set Flex 160 (BagCone OD22): 2024-10-16
• 04048675035695 - Hook ring LITESTAR,15mm,conn.: 2024-10-10
• 04048675035701 - Hook ring LITESTAR,22mm,conn.: 2024-10-10
• 04048675246558 - Babytherm 8010 System: 2024-08-23
• 04048675703853 - HME HumidStar 2 Plus Luer-Lock: 2024-07-30
• 04048675540137 - Disposable Handle Polaris, Single: 2024-07-18