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SedLine

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name
SedLine FDA UDI
Generic Name
Patient monitoring system module, electroencephalographic FDA UDI
Device Name
SedLine Module FDA UDI
Model / Reference
4432 FDA UDI
Description
SedLine Module FDA UDI

Identifiers

Catalog Number
4432 FDA UDI
Primary DI / UDI-DI
00843997013475 FDA UDI
FDA Product Code
OLW FDA UDI
GMDN Term
Patient monitoring system module, electroencephalographic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 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

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: Patient monitoring system module, electroencephalographic

SedLine by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, electroencephalographic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Masimo Corporation

Sources (1)

  • FDA UDI 125bed2c-2bb9-4d74-9963-35ccf1b06700 35 fields · synced Jun 8, 2026