ACTion Fuser Pump, 400ml, 1-6 ml/hrDual 190mm caut 418113400

GUDID 05707480110759

ACTion Fuser 400,1-6, Dual 190 Cath Cut, 9"Int,Flow Splitter

Ambu A/S

Elastomeric infusion pump kit

• Primary Device ID: 05707480110759
• NIH Device Record Key: 4e4a0ab2-67ca-490d-a329-7950220e0610
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTion Fuser Pump, 400ml, 1-6 ml/hrDual 190mm caut
• Version Model Number: 418113400
• Catalog Number: 418113400
• Company DUNS: 305682023
• Company Name: Ambu A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com

Device Dimensions

• Total Volume: 400 Milliliter
• Length: 190 Millimeter
• Total Volume: 500 Milliliter

Operating and Storage Conditions

• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480110612 [Primary]
GS1	05707480110759 [Package]; Contains: 05707480110612; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061409

FDA Product Code

• MEB: PUMP, INFUSION, ELASTOMERIC

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: 2018-07-16
• Device Publish Date: 2016-09-21

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