FDA Registration
Active
🇺🇸 United States
MED MICHIGAN HOLDINGS LLC
Reg #: 3017540705
·
FEI: 3017540705
·
Expires 2026
Products
8
Proprietary Names
62
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- MED MICHIGAN HOLDINGS LLC
- Registration Number
- 3017540705
- FEI Number
- 3017540705
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1017 4th Ave
- City
- Lake Odessa
- State
- MI
- ZIP
- 48849
- Country
- US
Regulatory Submissions
- 510(k) Number
- K964199
Owner / Operator
- Firm Name
- MED Michigan Holdings LLC
- Operator Number
- 10078584
- Address
- 1017 4th Ave
- City
- Lake Odessa
- State
- MI
- Postal Code
- 48849
- Country
- US
- Correspondent
- James Wisniewski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2020-10-28 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2020-10-28 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2020-10-28 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2020-10-28 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2020-10-28 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2020-10-28 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2020-10-28 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 2020-10-28 |
Proprietary Names
Blowmister
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Rigid Stylet, Smooth Balloon
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, No Stylet, Textured Balloon, Stopcock
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Sure Touch® Handle, Textured Balloon, Stopcock
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Guidewire Stylet, Smooth Balloon
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Rigid Stylet, Textured Balloon, Stopcock
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Guidewire Stylet, Textured Balloon, Stopcock
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Rigid Stylet, Smooth Balloon, Stopcock
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Sure Touch® Handle, Smooth Balloon
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Guidewire Stylet, Smooth Balloon, Stopcock
Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Sure Touch® Handle, Smooth Balloon, Stopcock
Retrograde Cardioplegia Cannula (Self Inflate) -15 Fr, Guidewire Stylet, Smooth Balloon
Retrograde Cardioplegia Cannula (Self Inflate) - 15 Fr, Rigid Stylet, Smooth Balloon
Retrograde Cardioplegia Cannula (Self Inflate) - 15 Fr, Sure Touch® Handle, Textured Balloon
Retrograde Cardioplegia Cannula (Self Inflate) - 15 Fr, Rigid Stylet, Textured Balloon
Retrograde Cardioplegia Cannula (Selfl Inflate) - 15 Fr, No Stylet, Smooth Balloon
Retrograde Cardioplegia Cannula (Self Inflate) - 15 Fr, Sure Touch® Handle, Smooth Balloon
Retrograde Cardioplegia Cannula (Self Inflate) -15 Fr, Guidewire Stylet, Textured Balloon
Suction Safety Device
Adult Tourniquet Kit with Snare
Vena Caval Tourniquet Kit with Snare
Pediatric Tourniquet Kit with Snare
Complete Adult Tourniquet Kit with Snare
Custom Tourniquet Kit with Snare
Perfusion Set, Y-Type with Vent
Perfusion Set, Straight
Perfusion Set, Recirculating
Multiple Perfusion Set with Vent
Multiple Perfusion Set
Perfusion Set, Y-Type
Vessel Cannula with Guyton Soft Tip
Internal Coronary Vessel Cannula
Perfusion Cannula
Saphenous Vein Cannula
Vessel Cannula
Direct Suction Adaptor
Peak Left Ventricular Vent Cannula (16Fr)
Peak Left Ventricular Vent Cannula (18Fr)
Peak Left Ventricular Vent Cannula (20Fr)
Myocardial Temperature Probe (15mm)
Myocardial Temperature Probe (18mm)
Myocardial Temperature Probe (44mm)
Myocardial Temperature Probe (30mm)
Rigid Intracardiac Sucker
Flexible Intracardiac Sucker
Rigid Mini Intracardiac Sucker
Extended Length Antegrade Cardioplegia Cannula with Vent
Antegrade Cardioplegia Cannula
Antegrade Cardioplegia Cannula with Vent
Extended Length Antegrade Cardioplegia Cannula
Coronary Artery Retraction Clips (3mm)
Coronary Artery Retraction Clips (5mm)
Phrenic Nerve Pad
Adult Cardiac Insulation Pad
Pediatric Cardiac Insulation Pad
10 Hole Tubing Organizer
8 Hole Tubing Organizer
8 Hole Tubing Organizer w/ Clips
Alpine Femoral Venous Catheter 20Fr, 22Fr, 24Fr, 26Fr, 28Fr
Mini Suture Guide
Straight Suture Guide
Curved Suture Guide
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility