FDA.reportPublic FDA data

Trulink

Primary DI
10841522127373
Brand
Trulink
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
NIBP Hoses and adapters
Catalog number
162-0047-01
Device description
SAMPLE LINE,AGENT,MALE LUER,SPU,7',50/BOX
Published
2024-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CBRANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112173000SPEACELABS MULTIGAS MODULESpacelabs Healthcare2011-10-05CBR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522127373PrimaryGS10
00841522127376Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084152212737310841522127373
00841522127376008415221273768415221273760841522127376

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, multiple-gasA small unit dedicated to the measurement of various gas concentrations, e.g., anaesthetic agents, oxygen (O2), carbon dioxide (CO2), in inspired and expired air obtained through a sampling tube connected to a main respiratory channel (mainstream) or a side-channel (sidestream) of a breathing circuit. 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 and the parent device then operates as a mainframe computer displaying the parameters measured and provided by this module.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
145581588
Device count
50
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841522105067UltraliteUltralite90217A-12016-10-21
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
10841522118401Spacelabs HealthcareDATUM130632182017-01-03
10841522118494Spacelabs HealthcareDATUM130121182016-12-29
10841522118562Spacelabs HealthcareDATUM130131182016-12-29
10841522118579Spacelabs HealthcareDATUM130131292016-12-29
10841522118593Spacelabs HealthcareDATUM130211182016-12-29
10841522118616Spacelabs HealthcareDATUM130221182016-12-29
10841522118685Spacelabs HealthcareDATUM130611182016-12-29
10841522118722Spacelabs HealthcareDATUM130613302016-12-29
10841522118753Spacelabs HealthcareDATUM130621182016-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyCBR2026-04-15
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBR2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBR2024-12-19
06944413815889Patient MonitorEdan Instruments, Inc.CBR2024-06-17
06944413815896Patient MonitorEdan Instruments, Inc.CBR2024-06-17
06944413815902Patient MonitorEdan Instruments, Inc.CBR2024-06-17
00841522127376TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-06-07
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-05-13
10841522127366TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-04-22
00841522127369TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-04-22
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCBR2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyCBR2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCBR2023-04-19
00195278524089NAGE Healthcare Finland OyCBR2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyCBR2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyCBR2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyCBR2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.CBR2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.CBR2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.CBR2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.CBR2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.CBR2022-04-12
00840682104135NAGE Healthcare Finland OyCBR2022-03-07
00840682104302NAGE Healthcare Finland OyCBR2022-03-07
00840682141291B1X5 Software UpgradeGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBR2020-11-18
00840682138574NAGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBR2020-11-16
00840682138581NAGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBR2020-11-16
06936415902360SMR integrated mount accessory KitShenzhen Mindray Bio-Medical Electronics Co., Ltd.CBR2020-05-06
06936415902650"19""display(adapter/2.3M"Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CBR2020-05-06
06936415902681"19""display(adapter/10M/VP1)"Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CBR2020-05-06