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

Basic Information

• Brand Name: SmartInfuser Set, 1-6ml/hr, with MultiBolus
• Primary DI: 05707480119370
• Version / Model: 418000511
• Company Name: Ambu A/S
• Labeler DUNS: 305682023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 77dd0062-391d-4b61-8714-41abec3f2825

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MEB	Pump, Infusion, Elastomeric	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47190	Elastomeric infusion pump kit	A collection of sterile devices designed to enable a healthcare provider or patient to perform infusion therapy using an elastomeric infusion pump. The kit typically consists of the infusion pump and other devices such as a catheter, tunneller, needle, sheath, syringe, dressings, adhesive strips, and a filling device for the infusion pump. This device is typically used for the infusion of fluids, antibiotics, chemotherapeutic agents, or pain management medications in the healthcare facility or the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05707480119387	GS1		8	In Commercial Distribution
Primary	05707480119370	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K061409	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -15 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -50 – 50 Degrees Celsius