ACTion Fuser Pump, 200ml, 1-6 ml/hr140mm caut-to-s 418103200

GUDID 05707480121571

ACTionFuser 200,1-6 ml/hr,140mm Cut-to-size,prosit, 6"Intro

Ambu A/S

Elastomeric infusion pump kit

• Primary Device ID: 05707480121571
• NIH Device Record Key: 189ee838-dead-45a8-88c3-26cfc749d272
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTion Fuser Pump, 200ml, 1-6 ml/hr140mm caut-to-s
• Version Model Number: 418103200
• Catalog Number: 418103200
• 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: 200 Milliliter
• Length: 140 Millimeter
• Total Volume: 300 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	05707480121458 [Primary]
GS1	05707480121571 [Package]; Contains: 05707480121458; 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

On-Brand Devices [ACTion Fuser Pump, 200ml, 1-6 ml/hr140mm caut-to-s]

• 05707480121595: ACTion Fuser 200,1-6 ml/hr,140mm Cut-to-size,prosit, 3.25"In
• 05707480121571: ACTionFuser 200,1-6 ml/hr,140mm Cut-to-size,prosit, 6"Intro