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Sage

FDA UDI

Class II (US FDA UDI)

by Xinmed Sdn. Bhd.

Identity

Trade Name
SAGE FDA UDI
Generic Name
Electrocardiographic lead set, single-use FDA UDI
Device Name
Disposable ECG Lead Wires/HP style/5-lead/Grabber/AHA/0.9M/Sage Services GROUP FDA UDI
Model / Reference
L01-05-DP FDA UDI
Description
Disposable ECG Lead Wires/HP style/5-lead/Grabber/AHA/0.9M/Sage Services GROUP FDA UDI

Identifiers

Primary DI / UDI-DI
09551028900007 FDA UDI
FDA Product Code
IKD FDA UDI
GMDN Term
Electrocardiographic lead set, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1175 FDA UDI
Commercial Distribution
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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiographic lead set, single-use

Sage by Xinmed Sdn. Bhd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead set, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xinmed Sdn. Bhd.

Sources (1)

  • FDA UDI 3f0b4f4f-2d21-4c4a-a68e-ea41abd91dc4 33 fields · synced Jun 6, 2026