X12+ Patient Cable

FDA UDI

Class II (US FDA UDI)

by Mortara Instrument, Inc.

Identity

Trade Name: X12+ Patient Cable FDA UDI
Generic Name: Electrocardiographic lead set, reusable FDA UDI
Device Name: Patient cable cleared with X12+ FDA UDI
Model / Reference: 9293-034-50 FDA UDI
Description: Patient cable cleared with X12+ FDA UDI

Identifiers

Primary DI / UDI-DI: 00812345023015 FDA UDI
510(k) Number: K081800 FDA UDI
K974149 FDA UDI
FDA Product Code: DQA FDA UDI
DRG FDA UDI
GMDN Term: Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2700 FDA UDI
870.2910 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

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrocardiographic lead set, reusable

X12+ Patient Cable by Mortara Instrument, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead set, reusable.

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Unimed — Unimed Medical Supplies, Inc. · Class II
Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II

Cleared under the same submission

K081800 also covers:

K974149 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

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Manufacturer

Manufacturer: Mortara Instrument, Inc.

Sources (1)

FDA UDI 7c9749c1-e271-47f9-8eec-a10afd3c62bb 36 fields · synced Jun 6, 2026