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Root

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name
Root FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
UHS Root NIBP, Temp, ISA NomoLine Capnography Kit FDA UDI
Model / Reference
9904 FDA UDI
Description
UHS Root NIBP, Temp, ISA NomoLine Capnography Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00843997014151 FDA UDI
510(k) Number
K191882 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 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

Yes

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: General-purpose multi-parameter bedside monitor

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

Similar devices

Also classified as General-purpose multi-parameter bedside monitor.

Cleared under the same submission

K191882 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Masimo Corporation

Sources (1)

  • FDA UDI 3cda7c2b-8b3e-4d67-8aad-741515f68092 35 fields · synced May 30, 2026