modification kit phototherapy

GUDID 04048675246312

Drägerwerk AG & Co. KGaA

Infant warmer

• Primary Device ID: 04048675246312
• NIH Device Record Key: 874b1530-2cc7-4791-b999-5d972cdd95d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: modification kit phototherapy
• Version Model Number: 2M30450
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675246312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954611

FDA Product Code

• LBI: Unit, Neonatal Phototherapy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

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