SmartInfuser Set, 1-6ml/hr, with MultiBolus

GUDID 05707480119387

Regulating Set 1-6 with MultiBolus, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)

Ambu A/S

Elastomeric infusion pump kit

• Primary Device ID: 05707480119387
• NIH Device Record Key: 77dd0062-391d-4b61-8714-41abec3f2825
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartInfuser Set, 1-6ml/hr, with MultiBolus
• Version Model Number: 418000511
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480119370 [Primary]
GS1	05707480119387 [Package]; Contains: 05707480119370; Package: [8 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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-19

Devices Manufactured by Ambu A/S

• 05707480164486 - Ambu® aScope™ 5 Cysto HD: 2024-11-14 Flexible Cystoscope, Reverse Deflection
• 05707480164516 - Ambu® aScope™ 5 Cysto HD: 2024-11-14 Flexible Cystoscope, Standard Deflection
• 05707480157136 - Ambu® aScope™ Duodeno 2: 2024-07-29 Duodenoscope
• 05707480006540 - Immobilization Kit, with: 2024-07-22 Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
• 05707480006557 - Immobilization Kit, with: 2024-07-22 Ambu® Mini Perfit ACE™ and Ambu® Head Wedge™, Small Pediatric and Pediatric
• 05707480037308 - Immobilization Kit, with: 2024-07-22 Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
• 05707480038626 - Immobilization Kit, with: 2024-07-22 Ambu® Military Perfit ACE™ and Ambu® Military Head Wedge™, Adult
• 05707480006601 - Silicone Face Mask: 2024-07-16 Reusable face mask