Device
Sterile Medical Device
Manufacturer
UNION PLASTIC
Model: Ø20mm with filter 15µm syringe first Catalog: 1MVA0031 DI: 03701225770187 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-13 Current Version: 2026-05-21
Description
Sterile Medical Device Use for transfer and mixing of drugs contained in vials.
Sterilization
Method Types - Sterilization Method: Radiation Sterilization
Device Sterile: Yes
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 55419f8d-17ac-4453-8996-7dbb39c43a00
Distribution Status: In Commercial Distribution
DUNS Number: 381128396
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 03701225770187
Type: Primary
Issuing Agency: GS1
GMDN
Code: 41222
Name: Medication transfer set
Definition:
A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.
FDA Product Codes
LHI
Set, I.V. Fluid Transfer
Premarket Submissions
Submission Number: K190149
Supplement Number: 000