SAM Medical Products

Address:12200 SW Tualatin Road,Tualatin,OR,97062,US

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Filters

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

Needle, Hypodermic, Single Lumen (FMI) (4) Clamp, Vascular (DXC) (2) Tourniquet Kit (OJS) (2) Device, Intravascular Catheter Securement (KMK) (1) Dressing, Wound, Drug (FRO) (1)

Premarket Exempt

Yes No

Clear

SAM Bleeding Control Kit - 00822045000254 Catalog Number :

Device Description : BLEEDING CONTROL KIT BASIC-VACCUM SEAL

Device Class : 1

Duns Number: 131084188

Premarket Exempt : Yes

Product Code : OJS

Prescription Use : No

Device Count : 1

SAM Bleeding Control Kit - 00822045000261 Catalog Number :

Device Description : BLEEDING CONTROL KIT BASIC-NO VACCUM

Device Class : 1

Duns Number: 131084188

Premarket Exempt : Yes

Product Code : OJS

Prescription Use : No

Device Count : 1

SAM IO Intraosseous Access System - 00822045000278 Catalog Number :

Device Description : SAM IO - 15 mm Needle Assembly - 1 Pack

Device Class :

Duns Number: 131084188

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

SAM IO Intraosseous Access System - 00822045000285 Catalog Number :

Device Description : SAM IO - 25mm Needle Assembly - 1 Pack

Device Class : 2

Duns Number: 131084188

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

SAM IO Intraosseous Access System - 00822045000292 Catalog Number :

Device Description : SAM IO - 45mm Needle Assembly - 1 Pack

Device Class : 2

Duns Number: 131084188

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

SAM IO Intraosseous Access System - 00822045000308 Catalog Number :

Device Description : SAM IO Stabilizer - 1 Pack

Device Class : 1

Duns Number: 131084188

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : Yes

Device Count : 1

SAM IO Intraosseous Access System - 00822045000322 Catalog Number :

Device Description : SAM IO - Adaptor - 1 Pack

Device Class : 2

Duns Number: 131084188

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Chito-SAM™ 100 - 00822045000339 Catalog Number :

Device Description : CHITOSAM 100, 3IN X 4FT

Device Class : U

Duns Number: 131084188

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

SAM® Junctional Tourniquet - 00822045000346 Catalog Number :

Device Description : SAM Junctional Tourniquet Trainer - SJT Belt with 2 TCDs, Auxiliary Strap, Exten SAM Junctional Tourniquet Trainer - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Hand Pump & Bag

Device Class : 2

Duns Number: 131084188

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SAM® Junctional Tourniquet - 00822045000353 Catalog Number :

Device Description : SAM Junctional Tourniquet - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Han SAM Junctional Tourniquet - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Hand Pump & Bag

Device Class : 2

Duns Number: 131084188

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

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