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MEDALink

FDA UDI

Class II (US FDA UDI)

by Rising Eagle Medical

Identity

Trade Name
MEDALink FDA UDI
Generic Name
Electrocardiographic lead set, single-use FDA UDI
Device Name
5 VLead, Pinch, Disp/SPU, Mindray Compatible, 50in, ECG Leadwire, 50/BX FDA UDI
Model / Reference
M-MR-5VPS-050 FDA UDI
Description
5 VLead, Pinch, Disp/SPU, Mindray Compatible, 50in, ECG Leadwire, 50/BX FDA UDI

Identifiers

Catalog Number
M-MR-5VPS-050 FDA UDI
Primary DI / UDI-DI
G096MMR5VPS0500 FDA UDI
FDA Product Code
DSA FDA UDI
GMDN Term
Electrocardiographic lead set, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2900 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiographic lead set, single-use

MEDALink by Rising Eagle Medical — 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
Rising Eagle Medical

Sources (1)

  • FDA UDI 616d323f-9225-43ff-869d-47d0786fed3d 34 fields · synced May 30, 2026