BAXTER HEALTHCARE CORPORATION

Address:ONE BAXTER PARKWAY,DEERFIELD,IL,60015,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

Agent, Absorbable Hemostatic, Collagen Based (LMF) (2) Agent, absorbable hemostatic, collagen based (LMF) (2) CLAMP, LINE (FKK) (2) Sealant,Polymerizing (NBE) (2) SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE (KDJ) (1) System, peritoneal, automatic delivery (FKX) (1)

Premarket Exempt

No Yes

Clear

MINICAP WITH POVIDONE-IODINE SOLUTION - 00085412007694 Catalog Number : 5C4466P

Device Description : This device is a plastic disconnect cap for peritoneal dialysis and contains pov

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : KDJ

Prescription Use : Yes

Device Count : 1

NA - 00085412025360 Catalog Number : 5C4527

Device Description : The Short Nose Clamp for Outlet Port of Plastic Container is designed to facilit

Device Class : 1

Duns Number: 005083209

Premarket Exempt : Yes

Product Code : FKK

Prescription Use : No

Device Count : 1

Easy-Lock - 00085412050829 Catalog Number : 5C4136

Device Description : This adapter consists of a spike connector, approx. 10.15 cm (4 inch) long, 3.81

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

ULTRACLAMP - 00085412070643 Catalog Number : 5C4957

Device Description : UltraClamp Tubing is designed to facilitate clamping of tubing on the UltraBag C

Device Class : 1

Duns Number: 005083209

Premarket Exempt : Yes

Product Code : FKK

Prescription Use : Yes

Device Count : 1

Coseal Surgical Sealant Replacement Applicator - 00085412083322 Catalog Number : 934033

Device Description : The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical

Device Class : 3

Duns Number: 628013963

Premarket Exempt : No

Product Code : NBE

Prescription Use : Yes

Device Count : 1

Coseal Surgical Sealant Extended Applicator - 00085412083339 Catalog Number : 934034

Device Description : The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical

Device Class :

Duns Number: 628013963

Premarket Exempt : No

Product Code : NBE

Prescription Use : Yes

Device Count : 1

Gelfoam Plus - 00085412086309 Catalog Number : 1501341

Device Description : GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical devic

Device Class : 3

Duns Number: 628013963

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

Floseal Special Applicator Tips - 00085412091006 Catalog Number : 1502186

Device Description : The FLOSEAL Malleable Tip and Trimmable Tip are intended for delivery of FLOSEAL

Device Class : 3

Duns Number: 628013963

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

Gelfoam Plus - 00085412095158 Catalog Number : 1503187

Device Description : GELFOAM® PLUS - COMPRESSED SPONGE is an implantable hemostat supplied as a ready

Device Class : 3

Duns Number: 628013963

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

Gelfoam Plus - 00085412095165 Catalog Number : 1503188

Device Description : GELFOAM® PLUS - POWDER is an implantable hemostat supplied as a ready to use med

Device Class : 3

Duns Number: 628013963

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

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