Babytherm 8010 System

GUDID 04048675246558

Drägerwerk AG & Co. KGaA

Infant warmer

• Primary Device ID: 04048675246558
• NIH Device Record Key: 542bea9f-c7ff-45ca-89bd-ed4ad127aa07
• Commercial Distribution Discontinuation: 2024-08-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Babytherm 8010 System
• Version Model Number: 2M22380
• 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
• Phone: +494518820
• Email: info@draeger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675017097 [Primary]
GS1	04048675246558 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971198

FDA Product Code

• FMT: Warmer, Infant Radiant

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: 2024-08-23
• Device Publish Date: 2015-10-24

Devices Manufactured by Drägerwerk AG & Co. KGaA

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• 04048675028987 - Angular porcelain bush: 2024-12-10
• 04048675180944 - Nozzle water vacuum gauge: 2024-12-10
• 04048675414605 - Silicone hose 6x2,5 2m: 2024-12-10
• 04048675692409 - Column/Head: 2024-12-10
• 04048675723035 - Vacusmart Tube (2m): 2024-12-10
• 04048675564553 - T-piece N for NO-A: 2024-10-16
• 04048675564577 - T-piece N for Nebulization: 2024-10-16