Ultraview

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name: Ultraview FDA UDI
Generic Name: Patient monitoring system module, multiple-gas FDA UDI
Device Name: MULTIGAS MODULE, 92518, REFURB FDA UDI
Model / Reference: Multigas Module FDA UDI
Description: MULTIGAS MODULE, 92518, REFURB FDA UDI

Identifiers

Catalog Number: R-92518 FDA UDI
Primary DI / UDI-DI: 10841522108846 FDA UDI
510(k) Number: K112173 FDA UDI
FDA Product Code: CCK FDA UDI
CBS FDA UDI
NHQ FDA UDI
CCL FDA UDI
CBR FDA UDI
NHP FDA UDI
NHO FDA UDI
CBQ FDA UDI
GMDN Term: Patient monitoring system module, multiple-gas FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1400 FDA UDI
868.1620 FDA UDI
868.1500 FDA UDI
868.1720 FDA UDI
868.1700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient monitoring system module, multiple-gas

Ultraview by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Patient monitoring system module, multiple-gas.

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GAS1 module: Auto ID Multi-Gas/O2/BIS mo — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
GAS2 module: Auto ID Multi-Gas/O2 module — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
WVSM Wireless Vital Signs Monitor — Athena Gtx · Class II
NomoLine — MASIMO CORPORATION · Class II

Cleared under the same submission

K112173 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Spacelabs Healthcare (washington), Inc

Sources (1)

FDA UDI 1274e50d-ec88-4bd8-b587-5cdc0f47a6c8 36 fields · synced May 30, 2026