FDA.reportPublic FDA data

Trulink

Primary DI
10841522127366
Brand
Trulink
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
NIBP Hoses and adapters
Catalog number
162-0046-01
Device description
SAMPLE LINE,AGENT,MALE LUER,SPU,10',50/BX
Published
2024-04-22
Public version status
Update
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
10841522127366PrimaryGS10
00841522127369Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084152212736610841522127366
00841522127369008415221273698415221273690841522127369

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

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
10841522127373TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-06-07
00841522127376TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-06-07
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-05-13
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