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EnSite™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
EnSite™ FDA UDI
Generic Name
Electrical-only medical device connection cable, reusable FDA UDI
Device Name
Recording System IC Output Cable FDA UDI
Model / Reference
ENSITE-CR-56-01 FDA UDI
Description
Recording System IC Output Cable FDA UDI

Identifiers

Catalog Number
ENSITE-CR-56-01 FDA UDI
Primary DI / UDI-DI
05415067033451 FDA UDI
510(k) Number
K202066 FDA UDI
K221213 FDA UDI
K223094 FDA UDI
K231415 FDA UDI
K242016 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Electrical-only medical device connection cable, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrical-only medical device connection cable, reusable

EnSite™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrical-only medical device connection cable, reusable.

Cleared under the same submission

K202066 also covers:

K221213 also covers:

K223094 also covers:

K231415 also covers:

K242016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI cfca1312-b7c1-4b2c-a089-46ce2dd9ab56 37 fields · synced Jun 8, 2026