FDA.reportPublic FDA data

Ultraview SL

Primary DI
10841522106439
Brand
Ultraview SL
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
Ultraview SL®
Catalog number
91496-U
Device description
OPTION,SPACELABS SPO2
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DQAOximeter
DSIDETECTOR AND ALARM, ARRHYTHMIA
DSKCOMPUTER, BLOOD-PRESSURE
DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
FLLThermometer, electronic, clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DSIDetector And Alarm, ArrhythmiaCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103142000SPACELABS MULTI-PARAMETER MODULESpacelabs Healthcare, Inc.2011-03-03DSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522106439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152210643910841522106439

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, multifunctionA small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
145581588
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841522131417Spacelabs HealthcarePatient cables & ECG leadwires700-0328-012025-09-03
10841522131424Spacelabs HealthcarePatient cables & ECG leadwires700-0330-012025-09-03
10841522125478Spacelabs HealthcarePatient cables & ECG leadwires50-00492018-08-10
10841522128790SPACELABS HEALTHCARE9022790227-182023-05-25
10841522105067UltraliteUltralite90217A-12016-10-21
10841522126857SPACELABS HEALTHCAREUltralite90217A-22019-02-28
10841522123177ABP9022790227-12017-09-15
10841522126864SPACELABS HEALTHCARE9022790227-22019-02-28
10841522131479XprezzonXprezzon Monitor913932024-12-04
10841522131455QubeQube Compact Monitor913902024-12-04
10841522103292Spacelabs Healthcare98400N/A2016-09-23
10841522125102PathfinderSLPathfinder SL040-1757-002018-06-19
10841522128851Eclipse ProEclipse Pro987002023-10-09
10841522100208Spacelabs Healthcare90499904992016-10-10
10841522118173Spacelabs HealthcareDATUM130132232017-01-03
10841522118258Spacelabs HealthcareDATUM130222572017-01-03
10841522118265Spacelabs HealthcareDATUM130232182017-01-03
10841522118326Spacelabs HealthcareDATUM130612182017-01-03
10841522118357Spacelabs HealthcareDATUM130622182017-01-03
10841522118371Spacelabs HealthcareDATUM130622522017-01-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06932825306064CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
00073796318321WIDE-RANGE D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00073796392437SMALL D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00816042016516FORAFORA CARE INC.DXN2026-07-20
00898939002758FORAFORA CARE INC.DXN2026-07-20
B353UB25511UbiqVue MultiparameterLifesignals, Inc.FLL2026-07-20
04538612230387FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.DSI2026-07-17
06953825911515N/AShenzhen Urion Technology Co., LtdDXN2026-07-16
00850044118670iHealthiHealth Labs Inc.DXN2026-07-14
00850044118687iHealthiHealth Labs Inc.DXN2026-07-14
00850078377234iHealthiHealth Labs Inc.DXN2026-07-14
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-07-13
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
06953825911416N/AShenzhen Urion Technology Co., LtdDXN2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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