EXACTAMIX

Basic Information

• Brand Name: EXACTAMIX
• Primary DI: 00085412477572
• Version / Model: H9381200-DY
• Catalog Number: H9381200-DY
• Company Name: BAXTER HEALTHCARE CORPORATION
• Labeler DUNS: 005083209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2023-07-20
• Public Version Status: Update
• Public Device Record Key: f4c0a3fe-9f85-416a-9049-bf41cb7a7e34

Device Description

EXACTAMIX Compounder, EM1200 Display

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEP	SYSTEM/DEVICE, PHARMACY COMPOUNDING	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17459	Intravenous solution compounder	A device that is typically exclusively used in the clinical pharmacy or a manufacturing plant for the production of intravenous (IV) fluids. These fluids will typically be distributed using the appropriate containers.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00085412477572	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 64 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity