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DDU-2XXX Series ECGMA Cable, IEC Configuration

FDA UDI

Class III (US FDA UDI)

by Defibtech, L.l.c.

Identity

Trade Name
DDU-2XXX Series ECGMA Cable, IEC Configuration FDA UDI
Generic Name
Electrocardiographic lead set, reusable FDA UDI
Model / Reference
DAC-2021 FDA UDI

Identifiers

Primary DI / UDI-DI
10815098020529 FDA UDI
510(k) Number
K121853 FDA UDI
FDA Product Code
MKJ FDA UDI
GMDN Term
Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.5310 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiographic lead set, reusable

DDU-2XXX Series ECGMA Cable, IEC Configuration by Defibtech, L.l.c. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead set, reusable.

Cleared under the same submission

K121853 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Defibtech, L.l.c.

Sources (1)

  • FDA UDI e736d6fe-57c2-46ed-9f5f-b85ff860b5e3 33 fields · synced May 30, 2026