VersaCell® X3

Basic Information

• Brand Name: VersaCell® X3
• Primary DI: 00630414595177
• Version / Model: 10793839
• Catalog Number: 10793839
• Company Name: SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
• Labeler DUNS: 186812384
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 3
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 19e74a30-2cf9-4414-903a-cc3ceb65d4c8

Device Description

VERSACELL X3 Instrument

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	Clinical Chemistry	862.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57871	Specimen processing instrument IVD	An electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414595177	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K970227	000