Restraint strap, replacement, carton of 10

GUDID 04049098000413

DRAEGER MEDICAL SYSTEMS, INC.

Transport infant incubator

• Primary Device ID: 04049098000413
• NIH Device Record Key: 0ab59fe7-21c3-43c0-b811-8f8e7a0a8f8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restraint strap, replacement, carton of 10
• Version Model Number: MU06011
• Company DUNS: 788289952
• Company Name: DRAEGER MEDICAL SYSTEMS, INC.
• Device Count: 10
• 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: false
• 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: +18004372437
• Email: info@draeger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049098000413 [Primary]
GS1	04049098058049 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941106

FDA Product Code

• FPL: Incubator, Neonatal Transport

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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