Who is the manufacturer of AMBULATORY ENTERAL NUTRITION PUMP?

Ross Product Div. Abbott Laboratories submitted the Traditional clearance for AMBULATORY ENTERAL NUTRITION PUMP (K003047).

What is the FDA product code for AMBULATORY ENTERAL NUTRITION PUMP?

LZH. It is classified under 21 CFR 880.5725 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for AMBULATORY ENTERAL NUTRITION PUMP?

510(k) clearance (submission type: Traditional).

AMBULATORY ENTERAL NUTRITION PUMP

K003047 · Ross Product Div. Abbott Laboratories · LZH · Jun 12, 2001 · General Hospital

Device Facts

Record ID	K003047
Device Name	AMBULATORY ENTERAL NUTRITION PUMP
Applicant	Ross Product Div. Abbott Laboratories
Product Code	LZH · General Hospital
Decision Date	Jun 12, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.