Ambu® ACTion™ Fuser Pump

Basic Information

• Brand Name: Ambu® ACTion™ Fuser Pump
• Primary DI: 05707480156085
• Version / Model: 418108200M
• Catalog Number: 418108200M
• Company Name: Ambu A/S
• Labeler DUNS: 305682023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-03
• Public Version: 1
• Public Version Date: 2022-02-11
• Public Version Status: New
• Public Device Record Key: 7b358edc-3a43-4539-8a7c-f275748684dc

Device Description

Action Fuser, 200 mL, 1-6 mL/hr Reg, Dual Cath, Splitter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• 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: No
• 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
46846	Mechanical infusion pump administration set	A collection of sterile devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication, typically for antibiotic therapy, chemotherapy, or pain management [including patient-controlled analgesia (PCA)] by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It typically consists of a reservoir (e.g., a plastic pouch), plastic tubing, a check valve, a line clamp, and Luer connectors. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05707480156078	GS1		5	In Commercial Distribution
Primary	05707480156085	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K061409	000

Device Sizes

Type	Value	Unit	Text
Total Volume	200	Milliliter

Storage Conditions

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