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HeartLight

FDA UDI

Class III (US FDA UDI)

by Cardiofocus, Inc.

Identity

Trade Name
HeartLight FDA UDI
Generic Name
Vascular balloon catheter fill-media FDA UDI
Device Name
Balloon Fill Media FDA UDI
Model / Reference
18-1342 FDA UDI
Description
Balloon Fill Media FDA UDI

Identifiers

Catalog Number
18-1342 FDA UDI
Primary DI / UDI-DI
00868976000130 FDA UDI
PMA Number
P150026 FDA UDI
FDA Product Code
OAE FDA UDI
GMDN Term
Vascular balloon catheter fill-media FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Total Volume — 95 Milliliter FDA UDI

Category: Vascular balloon catheter fill-media

HeartLight by Cardiofocus, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P150026 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardiofocus, Inc.

Sources (1)

  • FDA UDI 70f44d2c-d4ed-48c9-8cda-4d88faaa68e5 38 fields · synced Jun 6, 2026