Set, I.V. Fluid Transfer

Basic Information

• Brand Name: Set, I.V. Fluid Transfer
• Primary DI: 00816513023425
• Version / Model: BG-006-08
• Company Name: MPS MEDICAL, INC
• Labeler DUNS: 079636164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-06
• Public Version: 1
• Public Version Date: 2021-01-14
• Public Version Status: New
• Public Device Record Key: eac3e88e-f706-455b-8c67-1cd9e14a46a8

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHI	Set, I.V. Fluid Transfer	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35072	Intravenous line filter	A sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816513023422	GS1	BOX	50	In Commercial Distribution
Primary	00816513023425	GS1

Premarket Submissions

Submission Number	Supplement Number
K955896	000