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9Line

FDA UDI

Class II (US FDA UDI)

by Rising Eagle Medical

Identity

Trade Name
9Line FDA UDI
Generic Name
Electrocardiographic lead set, single-use FDA UDI
Device Name
5 Lead, Pinch, SPU Shielded ECG Leadwires, 50in, Draeger Comp, AAMI, 50/BX FDA UDI
Model / Reference
DR-5PS-050 FDA UDI
Description
5 Lead, Pinch, SPU Shielded ECG Leadwires, 50in, Draeger Comp, AAMI, 50/BX FDA UDI

Identifiers

Catalog Number
DR-5PS-050 FDA UDI
Primary DI / UDI-DI
G096DR5PS0500 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiographic lead set, single-use

9Line 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 27f8fa92-4cd0-44ec-aee4-a12132fabc25 35 fields · synced Jun 1, 2026