Dimension® QuikLYTE® Multisensor Flush Solution

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Dimension® QuikLYTE® Multisensor Flush Solution FDA UDI
Generic Name: Multiple electrolyte IVD, reagent FDA UDI
Device Name: Flush Solution, 3x1000mL FDA UDI
Model / Reference: 10445051 FDA UDI
Description: Flush Solution, 3x1000mL FDA UDI

Identifiers

Catalog Number: S630 FDA UDI
Primary DI / UDI-DI: 00842768014307 FDA UDI
510(k) Number: K970330 FDA UDI
FDA Product Code: CGZ FDA UDI
CEM FDA UDI
JGS FDA UDI
JFL FDA UDI
GMDN Term: Multiple electrolyte IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1170 FDA UDI
862.1600 FDA UDI
862.1665 FDA UDI
862.1160 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple electrolyte IVD, reagent

Dimension® QuikLYTE® Multisensor Flush Solution by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Multiple electrolyte IVD, reagent.

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Dimension Vista® V-LTYE® Dilution Check — Siemens Healthcare Diagnostics · Class II
Dimension® QuikLYTE® Integrated Multisensor Sample Diluent — Siemens Healthcare Diagnostics · Class II

Cleared under the same submission

K970330 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 63b0e9e5-7654-4b99-a689-e2f996523b7f 37 fields · synced May 30, 2026