BAYER MEDICAL CARE INC.

Address:625 Alpha Dr,Pittsburgh,PA,15238,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Injector And Syringe, Angiographic (DXT) (6) System, Nuclear Magnetic Resonance Imaging (LNH) (4)

Premarket Exempt

No Yes

Clear

CT TRI-PAK Sterile Disposable Syringe - 00616258005430 Catalog Number : CTP-200-FLS

Device Description : Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Con Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube)(CT - 200ML ENV/VIST SYRINGE KIT W/QFT)(60728656)

Device Class :

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Disposable MRI Kit with Check Valve - 00616258005447 Catalog Number : SQK 65VS

Device Description : Spectris MR Injector Kit (Includes: (2) 65 ML Front Load syringes, 96" low press Spectris MR Injector Kit (Includes: (2) 65 ML Front Load syringes, 96" low pressure tubing with an integrated check valve, 1 large spike for loading saline, 1 small spike(MR - SPECTRIS SYRINGE KIT, 2-65ML, CV)(60728532)

Device Class :

Duns Number: 058716649

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve - 00616258005454 Catalog Number : SSIT 96VLD

Device Description : 96" low pressure connector tube with T-connector and check valve for Spectris So 96" low pressure connector tube with T-connector and check valve for Spectris Solaris(MR - 96" T-CONNECT TUBING W/CHECK VALVE)(60728974)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Saline Syringe & Tubing for MR Injector System - 00616258005461 Catalog Number : SSQK 115

Device Description : Saline Syringe & Tubing for MR Injector System(KIT,115ML 96" CT/INT T/CV,MRI, MR Saline Syringe & Tubing for MR Injector System(KIT,115ML 96" CT/INT T/CV,MRI, MR,MC)(60728605)

Device Class :

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Disposable MRI Kit with Check Valve - 00616258005478 Catalog Number : SQK 65VA

Device Description : Spectris MR KIT,SYR/SPIKE/T,65ML FLS,MRI,BURRON and FFA 50(MR - SPECTRIS SYRINGE Spectris MR KIT,SYR/SPIKE/T,65ML FLS,MRI,BURRON and FFA 50(MR - SPECTRIS SYRINGE KIT, 2-65ML, FFA50)(60728524)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

CT TRI-PAK Sterile Disposable Syringe - 00616258005485 Catalog Number : CTP-125-FLS

Device Description : Tri-Pak (Includes:125 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Con Tri-Pak (Includes:125 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube)(CT - 125ML ENV/VIST SYR KIT W/QFT,LPCT)(60728613)

Device Class :

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

200mL Sterile Disposable Qwik-Fit Syringe & QFT - 00616258005492 Catalog Number : 200-FLS-Q

Device Description : Envision, Vistron, MCT- 200 ml syringe with quick fill tube(CT - 200ML ENV/VIST Envision, Vistron, MCT- 200 ml syringe with quick fill tube(CT - 200ML ENV/VIST SYRINGE KIT W/QFT)(60728648)

Device Class :

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

200mL Sterile Disposable Qwik-Fit Syringe - 00616258005508 Catalog Number : 200-FLS

Device Description : Envision, Vistron, MCT- 200 ml syringe(CT - 200ML ENV/VIST SYRINGE KIT)(60728621)

Device Class :

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Disposable MRI Kit A Disposable Kit for use with the 65/65 MR Injector from Baye - 00616258005515 Catalog Number : SQK 65S

Device Description : MRI Integral ”T” with Check Valve for MEDRAD® Spectris MR Injector (Contents: 1 MRI Integral ”T” with Check Valve for MEDRAD® Spectris MR Injector (Contents: 1 - 96" Low Pressure Connector Tube with T-Connector and Check Valve)(MR - SPECTRIS SYRINGE KIT, 2-65ML)(60728516)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector - 00616258005522 Catalog Number : SIT 96V

Device Description : Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way c Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a female-to-female adaptor) for pre-filled syringes(MR - 96" T-CONN TUBING W/CHECK VALVE, V)(60728923)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

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