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Pacel™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical Cardiovascular Division

Identity

Trade Name
Pacel™ FDA UDI
Generic Name
Temporary cardiac pacing balloon catheter FDA UDI
Device Name
Flow Directed Pacing Catheter FDA UDI
Model / Reference
401762 FDA UDI
Description
Flow Directed Pacing Catheter FDA UDI

Identifiers

Catalog Number
401762 FDA UDI
Primary DI / UDI-DI
05414734001045 FDA UDI
FDA Product Code
LDF FDA UDI
GMDN Term
Temporary cardiac pacing balloon catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3680 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

Yes

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

Dimensions & Sizes

Size
Catheter Gauge — 5 French FDA UDI

Category: Temporary cardiac pacing balloon catheter

Pacel™ by St. Jude Medical Cardiovascular Division — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temporary cardiac pacing balloon catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical Cardiovascular Division

Sources (1)

  • FDA UDI 840284e4-a19a-4890-b2db-c0a14255dbb2 37 fields · synced Jun 8, 2026