Sjm™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: SJM™ FDA UDI
Generic Name: Pin-indexed adaptor, reusable FDA UDI
Model / Reference: 2002 FDA UDI

Identifiers

Catalog Number: 2002 FDA UDI
Primary DI / UDI-DI: 05414734405331 FDA UDI
510(k) Number: K130545 FDA UDI
FDA Product Code: GZF FDA UDI
GZB FDA UDI
GMDN Term: Pin-indexed adaptor, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5870 FDA UDI
882.5880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pin-indexed adaptor, reusable

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

Similar devices

Also classified as Pin-indexed adaptor, reusable.

Superior Products Inc — Superior Products, LLC · Class I
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
YOKE, CGA-940 X 1/4 MALE WITH CHECK VALVE — Bay Corporation · Class I
Superior Products Inc — Superior Products, LLC · Class I
Superior Products Inc — Superior Products, LLC · Class I
Sarns™ Centrifugal Pump Adapter — Terumo Cardiovascular Systems Corporation · Class II
Superior Products Inc — Superior Products, LLC · Class I
Western/Scott Fetzer — Western Enterprises, Inc. · Class I

Cleared under the same submission

K130545 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI b05d556f-9130-479b-b3ae-b0e60a5e3e5a 36 fields · synced May 31, 2026