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Heart-Chill Cardiac & Phrenic Insulator

FDA UDI

Class II (US FDA UDI)

by Genesee Biomedical, Inc.

Identity

Trade Name
Heart-Chill Cardiac & Phrenic Insulator FDA UDI
Generic Name
Cardiac insulation pad FDA UDI
Device Name
Cardiac & Phrenic Insulator FDA UDI
Model / Reference
CPI-L FDA UDI
Description
Cardiac & Phrenic Insulator FDA UDI

Identifiers

Primary DI / UDI-DI
B040CPIL14 FDA UDI
510(k) Number
K874927 FDA UDI
FDA Product Code
DWC FDA UDI
GMDN Term
Cardiac insulation pad FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4250 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

No

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

Category: Cardiac insulation pad

Heart-Chill Cardiac & Phrenic Insulator by Genesee Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac insulation pad.

Cleared under the same submission

K874927 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genesee Biomedical, Inc.

Sources (1)

  • FDA UDI ed4476fd-3fa8-4c3e-b9f8-9c64ec797fbb 35 fields · synced Jun 6, 2026