Med Michigan Holdings, LLC

Address:2140 Oak Industrial Drive NE,Grand Rapids,MI,49505,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

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (6) Accessory Equipment, Cardiopulmonary Bypass (KRI) (2) Carrier, Ligature (GEJ) (1) Clamp, Surgical, General & Plastic Surgery (GDJ) (1)

Premarket Exempt

Yes No

Clear

Terumo Cardiovascular Systems - 00817278010842 Catalog Number : 820356

Device Description : Retrograde Cardioplegia Cannula, Manual Inflate, Smooth Balloon, Rigid Stylet, 15Fr

Device Class : 2

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Terumo Cardiovascular Systems - 00817278010859 Catalog Number : 816502L

Device Description : Retrograde Cardioplegia Cannula, Self Inflate, Med Balloon, Rigid Stylet, Sure T Retrograde Cardioplegia Cannula, Self Inflate, Med Balloon, Rigid Stylet, Sure Touch, Long, 15Fr

Device Class : 2

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Terumo Cardiovascular Systems - 00817278010866 Catalog Number : 816504L

Device Description : Retrograde Cardioplegia Cannula, Self Inflate, Textured Balloon, Rigid Stylet, S Retrograde Cardioplegia Cannula, Self Inflate, Textured Balloon, Rigid Stylet, Sure Touch, Long, 15Fr

Device Class : 2

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010880 Catalog Number : SUT-014

Device Description : Curved Suture Guide, 4 Pack

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : GEJ

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010910 Catalog Number : TOU-7903S-100

Device Description : Pediatric Tourniquet Kit wSnare, 1 red 2 blue 3 clear, 5.5" length, 100ct

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010927 Catalog Number : PER-1408S

Device Description : Multiple Perfusion Set w/Three One Way Cannula (PER-3001S)

Device Class : 2

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010934 Catalog Number : RSR-T014S-L

Device Description : Retrograde Cardioplegia Cannula, Self Inflating Text. Balloon (18mm) w/Rigid Sty Retrograde Cardioplegia Cannula, Self Inflating Text. Balloon (18mm) w/Rigid Stylet, 12.5” length, 15Fr

Device Class : 2

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010941 Catalog Number : RMR-0015S

Device Description : Retrograde Cardioplegia Cannula, Manually Inflating Balloon and Rigid Stylet, 15Fr

Device Class : 2

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010958 Catalog Number : 213-003

Device Description : Tubing Organizer, 10 Hole

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010965 Catalog Number : 213-003NS

Device Description : 10 Hole Tubing Organizer, Non-Sterile

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : Yes

Device Count : 1

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