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MC3 Opus(tm) Vascular Access Kit

FDA UDI

Class II (US FDA UDI)

by Michigan Critical Care Consultants, Inc.

Identity

Trade Name
MC3 Opus(tm) Vascular Access Kit FDA UDI
Generic Name
Mobile extracorporeal gas exchange system catheter kit FDA UDI
Device Name
Vascular Access Kit FDA UDI
Model / Reference
21030 FDA UDI
Description
Vascular Access Kit FDA UDI

Identifiers

Catalog Number
21030 FDA UDI
Primary DI / UDI-DI
10854916006833 FDA UDI
FDA Product Code
DRE FDA UDI
GMDN Term
Mobile extracorporeal gas exchange system catheter kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Mobile extracorporeal gas exchange system catheter kit

MC3 Opus(tm) Vascular Access Kit by Michigan Critical Care Consultants, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mobile extracorporeal gas exchange system catheter kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Michigan Critical Care Consultants, Inc.

Sources (1)

  • FDA UDI 3fe0e9d5-3dcb-41c4-968b-07112541d85e 34 fields · synced Jun 8, 2026