BAYER MEDICAL CARE INC.

Address:1 Bayer Drive,INDIANOLA,PA,15051,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) (10)

Premarket Exempt

No Yes

Clear

MEDRAD® Mark V ProVis Sterile Disposable Syringe 150mL & QFT - 00616258005539 Catalog Number : 150-FT-Q

Device Description : 150 ML FasTurn Syringe with Quick Fill Tube(SET,PKG,150ML FT,W/QFT,RAD,JAPAN,MC)(60729679)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube - 00616258005546 Catalog Number : ART 700 SYR

Device Description : SYRINGE KIT,PACKAGED,,150FT,MK 7(ANGIO-ARTERION, 150ML SYR KIT W/QFT,MC)(60729385)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Avanta Multi-Patient Disposable Syringe - 00616258005553 Catalog Number : AVA 500 MPAT (Part 1 of 2)

Device Description : Avanta Multi-Patient Disposable Set(SET, PKG, MEDRAD AVANTA, SYRINGE, RAD S)(60729407)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Avanta Multi-Patient Disposable Hand Controller - 00616258005560 Catalog Number : AVA 500 HC

Device Description : Avanta Hand-Controller(MEDRAD AVANTA HAND CONTROLLER)(60729520)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Mark V ProVis 60mL FasTurn Sterile Disposable Syringe & QFT - 00616258005577 Catalog Number : 60-FT-Q

Device Description : 60 ML FasTurn Syringe with Quick Fill Tube(ANGIO-SET,PKG,60ML FASTURN SYR W/QFT, 60 ML FasTurn Syringe with Quick Fill Tube(ANGIO-SET,PKG,60ML FASTURN SYR W/QFT,MC)(60729598)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Mark V ProVis 150mL FasTurn Sterile Disposable Syringe - 00616258005584 Catalog Number : 150-FT

Device Description : 150 ML FasTurn Syringe(ANGIO - SET, PKG, 150ML FASTURN SYR, MC)(60729601)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Mark V ProVis 150mL FasTurn Sterile Disposable Syringe - 00616258005591 Catalog Number : 150-FT

Device Description : 150 ML FasTurn Syringe(SET,PKG,150ML FASTURN,RAD,JAPAN,MC)(60729628)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Mark V ProVis Sterile Disposable Syringe 150mL & QFT - 00616258005607 Catalog Number : 150-FT-Q

Device Description : 150 ML FasTurn Syringe with Quick Fill Tube(ANGIO-SET,PKG,150ML FASTURN SYR W/QF 150 ML FasTurn Syringe with Quick Fill Tube(ANGIO-SET,PKG,150ML FASTURN SYR W/QFT,MC)(60729636)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe - 00616258005614 Catalog Number : 200-FT

Device Description : 200 ML FasTurn Syringe(ANGIO - SET, PKG, 200ML FASTURN SYR, MC)(60729687)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe & QFT - 00616258005621 Catalog Number : 200-FT-Q

Device Description : 200 ML FasTurn Syringe with Quick Fill Tube(ANGIO-SET,PKG,200ML FASTURN SYR W/QF 200 ML FasTurn Syringe with Quick Fill Tube(ANGIO-SET,PKG,200ML FASTURN SYR W/QFT,MC)(60729695)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

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