EXACTAMIX

Basic Information

• Brand Name: EXACTAMIX
• Primary DI: 05413765492020
• Version / Model: H938G174
• Catalog Number: H938G174
• Company Name: BAXTER CORPORATION ENGLEWOOD
• Labeler DUNS: 078383477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: 7b73a058-5836-4d5b-9fa4-367d1b9af2e6

Device Description

EXACTAMIX Inlet, Vented, High-Volume Inlet

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: 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
NEP	SYSTEM/DEVICE, PHARMACY COMPOUNDING	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41646	Compounding transfer set	A collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	55413765492025	GS1	CASE	25	In Commercial Distribution
Primary	05413765492020	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K002705	000