Who is the manufacturer of INTER-VIAL?

Duoject Medical Systems, Inc. submitted the Traditional clearance for INTER-VIAL (K010703).

What is the FDA product code for INTER-VIAL?

LHI. It is classified under 21 CFR 880.5440 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for INTER-VIAL?

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

INTER-VIAL

K010703 · Duoject Medical Systems, Inc. · LHI · Jun 25, 2001 · General Hospital

Device Facts

Record ID	K010703
Device Name	INTER-VIAL
Applicant	Duoject Medical Systems, Inc.
Product Code	LHI · General Hospital
Decision Date	Jun 25, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5440
Device Class	Class 2

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.