Acquity

Basic Information

• Brand Name: Acquity
• Primary DI: 00816776020117
• Version / Model: 186015043IVD
• Catalog Number: 186015043IVD
• Company Name: WATERS TECHNOLOGIES CORPORATION
• Labeler DUNS: 107186004
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-04
• Public Version: 3
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 01231a6f-a1f9-44e7-b1ec-e459fc888626

Device Description

ACQUITY UPLC Column Manager-A (CM-A), IVD)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
LDM	Instrumentation, High Pressure Liquid Chromatography	Clinical Chemistry	862.2260	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57845	High performance liquid chromatography analyser IVD	An electrically-powered automated or semi-automated laboratory instrument designed for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. Chemical components are separated by passing pressurized liquid through a narrow column to allow the various components to separate based on their chemical/physical properties while interacting with column filling. As the substances exit the column they are detected and identified electronically or spectrometrically. The device is used for the identification of complex substances such as drugs and hormones.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816776020117	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: – 85 Percent (%) Relative Humidity