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Surge Cardiovascular

FDA UDI

Class II (US FDA UDI)

by Med Michigan Holdings Llc

Identity

Trade Name
Surge Cardiovascular FDA UDI
Generic Name
Cardioplegia cannula FDA UDI
Device Name
Retrograde Cardioplegia Cannula, Self Inflating Balloon (18mm) and Rigid Stylet FDA UDI
Model / Reference
RSR-M014S FDA UDI
Description
Retrograde Cardioplegia Cannula, Self Inflating Balloon (18mm) and Rigid Stylet FDA UDI

Identifiers

Catalog Number
RSR-M014S FDA UDI
Primary DI / UDI-DI
00817278011368 FDA UDI
FDA Product Code
DWF FDA UDI
GMDN Term
Cardioplegia cannula FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4210 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

No

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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Cardioplegia cannula

Surge Cardiovascular by Med Michigan Holdings Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardioplegia cannula.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Med Michigan Holdings Llc

Sources (1)

  • FDA UDI 4ff36c83-096c-4f64-8318-a6ad2f0ecda7 34 fields · synced Jun 8, 2026