Device
264" COILED MRI EXT SET. Fixed Male/Female Luers. Standard Pinch Clamp
Manufacturer
DRAGON HEART MEDICAL, INC.
DRAGON HEART MEDICAL, INC.
Model: SMCE264
Catalog: SMCE264
DI: B346SMCE2640
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
264" COILED MRI EXT SET. Fixed Male/Female Luers. Standard Pinch Clamp
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
47e53632-3d26-474f-9dc2-10cc072ffda4
Distribution Status:
In Commercial Distribution
DUNS Number:
841522985
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
Yes
Labeled Contains NRL:
Yes
Labeled No NRL:
No
Identifiers
Device ID:
B346SMCE2640
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 58977
Name: Basic intravenous administration set, noninvasive
Definition:
A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.
FDA Product Codes
FPA
Set, Administration, Intravascular