FDA.reportPublic FDA data

RIKEN KEIKI Co.,Ltd.

Primary DI
04571501890019
Brand
RIKEN KEIKI Co.,Ltd.
Company
RIKEN KEIKI CO.,LTD.
Model
FI-8000
Catalog number
PC3E-0421
Device description
ANALYZER,GAS,HALOTANE,GASEOUS-PHASE(ANESTHETICCONC.)
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04571501890019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04571501890019045715018900194571501890019

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia vaporizer testerA device designed to evaluate and display the performance of an anaesthetic vaporizer; it may also be used to assist in the calibration of the vaporizer. Currently, most types are electronic but some may be mechanical. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690573670
Device count
1
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00840682147811CARESCAPE SoftwareGE Healthcare Finland OyCBS2026-04-15
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2024-12-19
06944413815889Patient MonitorEdan Instruments, Inc.CBS2024-06-17
06944413815896Patient MonitorEdan Instruments, Inc.CBS2024-06-17
06944413815902Patient MonitorEdan Instruments, Inc.CBS2024-06-17
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCBS2024-05-13
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCBS2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyCBS2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCBS2023-04-19
00195278524089NAGE Healthcare Finland OyCBS2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyCBS2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyCBS2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyCBS2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682104135NAGE Healthcare Finland OyCBS2022-03-07
00840682104302NAGE Healthcare Finland OyCBS2022-03-07
00840682141291B1X5 Software UpgradeGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBS2020-11-18
00840682138574NAGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBS2020-11-16
00840682138581NAGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBS2020-11-16
B510PM2000M1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
B510PM2000TM1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
B510PM2000XL1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
B510PM2000XLPLUS1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
B510PM2000XLPRO1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
00840682143806CARESCAPE B650GE Healthcare Finland OyCBS2020-03-11