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Midmark

FDA UDI

Class II (US FDA UDI)

by Midmark Corporation

Identity

Trade Name
Midmark FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
IQvitals Zone, Wireless Monitor, with Serenity BP, Exergen TemporalScanner and Nellcor SpO2 FDA UDI
Model / Reference
IQvitals Zone, w/Nellcor SPO2 and Wirless FDA UDI
Description
IQvitals Zone, Wireless Monitor, with Serenity BP, Exergen TemporalScanner and Nellcor SpO2 FDA UDI

Identifiers

Catalog Number
1-200-0350 FDA UDI
Primary DI / UDI-DI
00841709105821 FDA UDI
FDA Product Code
DXN FDA UDI
MWI FDA UDI
FLL FDA UDI
DQA FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
870.2300 FDA UDI
880.2910 FDA UDI
870.2700 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: General-purpose multi-parameter bedside monitor

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

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Midmark Corporation

Sources (1)

  • FDA UDI 97faac7a-cb35-4cf1-a6b8-6980420c9d14 37 fields · synced Jun 8, 2026