FDA.reportPublic FDA data

Ultraview

Primary DI
10841522107764
Brand
Ultraview
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
91424
Catalog number
L-91424-A
Device description
BASE UNIT, SV02/SCV02 MODULE, 91424, LOANER ONLY
Published
2017-03-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K893867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893867000CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULESpacelabs, Inc.1989-09-13DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522107764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152210776410841522107764

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, intracardiac oximetryA small unit designed to measure the ratio of oxyhaemoglobin (O2Hb) to reduced haemoglobin (RHb) and/or deoxyhaemoglobin (HHb) within the heart by comparing the absorption of red and infrared light in the blood [mixed venous oxygen saturation (SvO2)]. A fibreoptic probe is inserted into the pulmonary artery, often a Swan-Ganz catheter, to detect the SvO2 levels. It is designed to operate as part of a patient monitoring system enhancing the function of this parent device. The module automatically plugs into the parent device when placed into a standardized slot in the parent device which then operates as a mainframe computer displaying the SvO2 information measured by this module.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
145581588
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841522130755Eclipse MiniEclipse Mini Patches712-1053-022024-06-07
10841522128769Eclipse MiniEclipse Mini989002024-03-15
10841522130298Eclipse ProEclipse Pro712-1052-012023-02-23
10841522100406Spacelabs HealthcareAbsorber122009022016-12-29
10841522100413Spacelabs HealthcareAbsorber122009032016-12-29
10841522128851Eclipse ProEclipse Pro987002023-10-09
10841522123122TrulinkAdapter Cables700-0290-002017-09-25
10841522128790SPACELABS HEALTHCARE9022790227-182023-05-25
10841522105067UltraliteUltralite90217A-12016-10-21
10841522126857SPACELABS HEALTHCAREUltralite90217A-22019-02-28
10841522123177ABP9022790227-12017-09-15
10841522126864SPACELABS HEALTHCARE9022790227-22019-02-28
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
10841522131479XprezzonXprezzon Monitor913932024-12-04
10841522131455QubeQube Compact Monitor913902024-12-04
10841522106439Ultraview SLUltraview SL®91496-U2016-10-07
10841522103292Spacelabs Healthcare98400N/A2016-09-23
10841522125102PathfinderSLPathfinder SL040-1757-002018-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
07290019919346OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
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07290019919438OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
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