FDA.reportPublic FDA data

Trulink

Primary DI
00841522127376
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
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145581588
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
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
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
10841522127373TrulinkSPACELABS 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