Dimension Vista System Flex reagent cartridge A1C KIT

Basic Information

• Brand Name: Dimension Vista System Flex reagent cartridge A1C KIT
• Primary DI: 00630414006666
• Version / Model: 10720885
• Catalog Number: K3105B
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-12
• Public Version: 4
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 8e76ee1e-adab-40ff-ac82-3c6baf7f2a9c

Device Description

A1C Reagent Kit

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: 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
PDJ	Hemoglobin A1c test system	Clinical Chemistry	862.1373	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59090	Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c) in a clinical specimen, using a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414006666	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173909	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius