Streamline™

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: STREAMLINE™ FDA UDI
Generic Name: External pacemaker, epicardial pacing FDA UDI
Device Name: WIRE 6495F TEMP PACE BIP MYO 6PK 20L FDA UDI
Model / Reference: 6495F FDA UDI
Description: WIRE 6495F TEMP PACE BIP MYO 6PK 20L FDA UDI

Identifiers

Primary DI / UDI-DI: 00613994365439 FDA UDI
510(k) Number: K012460 FDA UDI
FDA Product Code: LDF FDA UDI
GMDN Term: External pacemaker, epicardial pacing 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

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

FDA UDI

Manufacturing Date

FDA UDI

Category: External pacemaker, epicardial pacing

Streamline™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External pacemaker, epicardial pacing.

CARDIOTRONIC — Osypka Medical, Inc. · Class II
Bloom — Fischer Medical · Class II
Osypka Medical — Osypka Medical, Inc. · Class II
Solo Pace Control System — SOLO PACE INC · Class II
PACE 203H — Oscor Inc. · Class II
CARDIOTRONIC — Osypka Medical, Inc. · Class II
CARDIOTRONIC — Osypka Medical, Inc. · Class II
Bloom — Fischer Medical · Class II

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

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Manufacturer

Manufacturer: Medtronic, Inc.

Sources (1)

FDA UDI 6a44fda0-5608-4e34-8cc3-cd724f2bfb91 36 fields · synced May 29, 2026