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® MRXperion Sterile Disposable MRI Kit - 00616258005058 Catalog Number : XP 65/115VS

Device Description : "Sterile Disposable MRI Kit(Kit,Syringe,65/115mL,MRXPERION)(85019937)"

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Stellant Sterile Disposable Syringe - 00616258005171 Catalog Number : SDS-CTP-QFT

Device Description : Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube(CT -

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Stellant Sterile Disposable Syringe - 00616258005188 Catalog Number : SDS-CTP-SPK

Device Description : Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(CT-ST

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Stellant Sterile Disposable Syringe - 00616258005201 Catalog Number : SSS-CTP-QFT

Device Description : Stellant Single Syringe Kit with LPDCT with T-Connector and 1 quick fill tube(CT

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Stellant Sterile Disposable Syringe - 00616258005218 Catalog Number : SSS-CTP-SPK

Device Description : Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(CT-

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Stellant Sterile Disposable Syringe - 00616258005225 Catalog Number : SSS-QFT

Device Description : Stellant Single Syringe and Quick Fill Tube(CT - STELLANT SINGLE SYR KIT, QFT)(60728842)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Stellant Sterile Disposable Syringe 200mL Syringe & Spike - 00616258005232 Catalog Number : SSS-SPK

Device Description : Stellant Single Syringe and Spike(CT - STELLANT SINGLE SYR KIT, SPIKE)(60728850)

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Stellant Sterile Disposable Syringe - 00616258005256 Catalog Number : SDS-CTP-SCS

Device Description : Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(CT -

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube - 00616258005263 Catalog Number : SSS-LP-60-T

Device Description : Stellant 60" low pressure connector tube with six-inch T-connector(CT - 60" T-CO

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube - 00616258005270 Catalog Number : SSS-LP-60

Device Description : Stellant 60" low pressure connector tube with prime tube(CT - 60" CONNECTOR TUBI

Device Class : 2

Duns Number: 058716649

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

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