HMG

Basic Information

• Brand Name: HMG
• Primary DI: 10850048235059
• Version / Model: 001
• Company Name: Hartman Medical Group LLC
• Labeler DUNS: 117654675
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-05-19
• Public Version: 1
• Public Version Date: 2023-05-29
• Public Version Status: New
• Public Device Record Key: d7bc9026-264e-4bf9-836c-089527edc683

Device Description

Macro Bore IV extension set with Needleless Y-site and removable Needleless Connector

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GAZ	Tubing, Noninvasive	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850048235052	GS1
Primary	10850048235059	GS1