Disposable MRI Kit for 65/115 MR Injector System

FDA UDI

Class II (US FDA UDI)

by Bayer Medical Care Inc.

Identity

Trade Name: Disposable MRI Kit for 65/115 MR Injector System FDA UDI
Generic Name: Angiographic syringe FDA UDI
Device Name: "Spectris Solaris MR Kit (Includes 65 ML Qwik-Fit Syringe, 115 ML Qwik-Fit Syringe for Saline, 1 large spike, 1 small spike for contrast, 96"" low pressure tubing with T-connector and Check Valve) (KIT,65/115ML,96""CT/CV,MRI, MC,JA) (84196983)" FDA UDI
Model / Reference: SSQK 65/115VS FDA UDI
Description: "Spectris Solaris MR Kit (Includes 65 ML Qwik-Fit Syringe, 115 ML Qwik-Fit Syringe for Saline, 1 large spike, 1 small spike for contrast, 96"" low pressure tubing with T-connector and Check Valve) (KIT,65/115ML,96""CT/CV,MRI, MC,JA) (84196983)" FDA UDI

Identifiers

Catalog Number: SSQK 65/115VS FDA UDI
Primary DI / UDI-DI: 00616258007144 FDA UDI
FDA Product Code: DXT FDA UDI
GMDN Term: Angiographic syringe FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Category: Angiographic syringe

Disposable MRI Kit for 65/115 MR Injector System by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Bayer Medical Care Inc.

Sources (1)

FDA UDI c1b652a5-685c-42f7-af4d-637a3c51e8a9 35 fields · synced Jun 9, 2026