N Cuvette Segments for BN ProSpec®

Basic Information

• Brand Name: N Cuvette Segments for BN ProSpec®
• Primary DI: 00842768012334
• Version / Model: 10446539
• Catalog Number: OVLK31
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 300
• Record Status: Published
• Publish Date: 2017-10-31
• Public Version: 6
• Public Version Date: 2024-02-26
• Public Version Status: Update
• Public Device Record Key: 2bbb4fec-130d-480e-8e11-369c7fa9b4c1

Device Description

The N Cuvette Segments are part of the BN ProSpec system.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JZW	NEPHELOMETER	Immunology	866.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61032	Laboratory analyser cuvette IVD, single-use	A small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for in vitro diagnostic testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through the contained material and is typically made of plastic, glass or quartz with a flat base and an open top. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768012334	GS1
Unit of Use	00842768024788	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K001647	000