Photo-Therapy 4000

GUDID 04048675242376

Drägerwerk AG & Co. KGaA

Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit Overhead infant phototherapy unit

• Primary Device ID: 04048675242376
• NIH Device Record Key: b3d8fb2b-892f-4d07-93e8-5abaea9b2313
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Photo-Therapy 4000
• Version Model Number: 2M22310
• 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	04048675041689 [Primary]
GS1	04048675242376 [Direct Marking]

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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