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LifeSync

FDA UDI

Class II (US FDA UDI)

by Advantage Medical Electronics, LLC

Identity

Trade Name
LifeSync FDA UDI
Generic Name
Electrocardiographic lead set, single-use FDA UDI
Device Name
5 Lead, LeadWear, Size 9L, Taiwan FDA UDI
Model / Reference
LS-229D FDA UDI
Description
5 Lead, LeadWear, Size 9L, Taiwan FDA UDI

Identifiers

Primary DI / UDI-DI
00849593005814 FDA UDI
510(k) Number
K030795 FDA UDI
FDA Product Code
DRG FDA UDI
GMDN Term
Electrocardiographic lead set, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2910 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

LifeSync by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K030795 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advantage Medical Electronics, LLC

Sources (1)

  • FDA UDI 8c0593ab-c18c-4713-950a-6b37bbc1cfcf 36 fields · synced Jun 1, 2026