ORGAN RECOVERY SYSTEMS, INC.

Address:One Pierce Place,Itasca,IL,60143,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

Set, Perfusion, Kidney, Disposable (KDL) (9) System, Perfusion, Kidney (KDN) (1)

Premarket Exempt

Clear

LifePort® Kidney Transporter - 00815045020162 Catalog Number :

Device Description : LifePort® Kidney Transporter Disposable Coupler

Device Class : 2

Duns Number: 078972580

Premarket Exempt : No

Product Code : KDL

Prescription Use : Yes

Device Count : 1

LifePort® Kidney Transporter - 00815045020186 Catalog Number :

Device Description : LifePort® Kidney Transporter Disposable SealRing® Cannula (10x35)

Device Class : 2

Duns Number: 078972580

Premarket Exempt : No

Product Code : KDL

Prescription Use : Yes

Device Count : 1

LifePort® Kidney Transporter - 00815045020209 Catalog Number :

Device Description : LifePort® Kidney Transporter Disposable Universal SealRing® Cannula (3mm)

Device Class : 2

Duns Number: 078972580

Premarket Exempt : No

Product Code : KDL

Prescription Use : Yes

Device Count : 1

LifePort® Kidney Transporter - 00815045020223 Catalog Number :

Device Description : LifePort® Kidney Transporter Disposable Universal SealRing® Cannula (5mm)

Device Class : 2

Duns Number: 078972580

Premarket Exempt : No

Product Code : KDL

Prescription Use : Yes

Device Count : 1

LifePort® Kidney Transporter - 00815045020247 Catalog Number :

Device Description : LifePort® Kidney Transporter Disposable Universal SealRing® Cannula (7mm)

Device Class : 2

Duns Number: 078972580

Premarket Exempt : No

Product Code : KDL

Prescription Use : Yes

Device Count : 1

LifePort® Kidney Transporter - 00815045020261 Catalog Number :

Device Description : LifePort® Kidney Transporter Disposable Universal SealRing® Cannula (9mm)

Device Class : 2

Duns Number: 078972580

Premarket Exempt : No

Product Code : KDL

Prescription Use : Yes

Device Count : 1

SPS-1® (UW Solution) - 00815045020285 Catalog Number :

Device Description : SPS-1® (UW Solution), Static Preservation Solution (500mL)

Device Class : 2

Duns Number: 078972580

Premarket Exempt : No

Product Code : KDL

Prescription Use : Yes

Device Count : 1

SPS-1® (UW Solution) - 00815045020308 Catalog Number :

Device Description : SPS-1® (UW Solution), Static Preservation Solution (1 Liter)

Device Class : 2

Duns Number: 078972580

Premarket Exempt : No

Product Code : KDL

Prescription Use : Yes

Device Count : 1

SPS-1® (UW Solution) - 00815045020322 Catalog Number :

Device Description : SPS-1® (UW Solution), Static Preservation Solution (2 Liter)

Device Class : 2

Duns Number: 078972580

Premarket Exempt : No

Product Code : KDL

Prescription Use : Yes

Device Count : 1

KPS-1® - 00815045020346 Catalog Number :

Device Description : KPS-1®, Machine Preservation Solution (1 Liter)

Device Class : 2

Duns Number: 078972580

Premarket Exempt : No

Product Code : KDN

Prescription Use : Yes

Device Count : 1

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