FDA.reportPublic FDA data

Infinium Medical Inc.

Primary DI
00852087007898
Brand
Infinium Medical Inc.
Company
INFINIUM MEDICAL, INC.
Model
OBA MRI Compatible Anesthesia Machine
Published
2024-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
BSZGas-Machine, Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSZGas-Machine, AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012446000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012446000OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRICharles A. Smith2001-10-03BSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852087007898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852087007898008520870078988520870078980852087007898

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia workstation, general-purposeAn assembly of electronic devices used for general inhalation anaesthesia (i.e., the delivery of oxygen (O2), nitrous oxide (N2O), other medical gases, and anaesthetic agents) and possibly total intravenous anaesthesia and local anaesthesia. Its main components are high, intermediate, and low pressure gas delivery systems, a breathing circuit (typically with a ventilator), and an anaesthetic gas scavenging system (AGSS). It has built-in alarms, analysers, control/monitoring systems, and typically has integrated circuitry/touchscreen displays for target controlled anaesthesia (TCA) for any type of patient (e.g., neonate, adult).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037504771
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852087007881Infinium Medical Inc.OBA Anesthesia Machine2024-05-06
00852087007577EdgeR802023-06-15
00852087007584Edge1602023-06-15
00852087007591Edge2002023-06-15
00852087007607Edge4002023-06-15
00852087007522Infinium MedicalOMNI II K2021-12-10
00852087007034Infinium MedicalOMNI III2017-03-06
00852087007003Infinium MedicalOMNI K2017-03-06
00852087007010Infinium MedicalOMNI Express2017-03-06
00852087007027Infinium MedicalOMNI II2017-03-06
00852087007041Infinium MedicalCLEO2017-03-06
00852087007058Infinium MedicalOMNI2017-03-06
00852087007065AxiaTRIA2017-03-06
00852087007072AxiaV1050T2017-03-06
00852087007089AxiaV1200T2017-03-06
00852087007096AxiaV1500A2017-03-06
00852087007102Schiller AmericasT Lite2017-03-06
00852087007119Schiller AmericasTranquility II2017-03-06
00852087007171Schiller AmericasTranquility VS2017-03-06
00820870070345Infinium MedicalOMNI III2017-03-06

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Primary DI, Brand, Company table
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00814905021431Codonics Safe Label System®(SLS) 630i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021455Codonics Safe Label System®(SLS) 700i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00816711020097ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEMPARKER-HANNIFIN CORPORATIONBSZ2025-09-24
00810085200130Ultra PC% Oral Surgery Package HACCUTRON, INC.BSZ2025-05-14
B510AM60001ADVANCED GAS-MACHINE ANESTHESIAADVANCED INSTRUMENTATIONS, INC.BSZ2025-02-07
05051977000857PenlonPENLON LTDBSZ2024-12-06
06936415980702A3 Anesthesia Delivery SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.BSZ2024-11-20
00852087007881Infinium Medical Inc.INFINIUM MEDICAL, INC.BSZ2024-05-06
00816711024439DIGITAL MDM ASSY-120V(STAND MTPARKER-HANNIFIN CORPORATIONBSZ2024-04-05
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00813830021141Flowmeter, CMACCUTRON, INC.BSZ2023-09-21
00813830027785Flowmeter, Digital FlushMount, INTACCUTRON, INC.BSZ2023-09-21
04048675556169Atlan A300 XLDrägerwerk AG & Co. KGaABSZ2023-09-21
04048675556176Atlan A350Drägerwerk AG & Co. KGaABSZ2023-09-21
04048675556183Atlan A350 XLDrägerwerk AG & Co. KGaABSZ2023-09-21
04048675556343Atlan A300Drägerwerk AG & Co. KGaABSZ2023-09-21
00813830026986FRU, Gauge Newport N2OACCUTRON, INC.BSZ2023-09-15
00813830026993FRU, Gauge Newport Int O2ACCUTRON, INC.BSZ2023-09-15
00813830024579Chair Conversion KitACCUTRON, INC.BSZ2023-09-14
00813830023626Ultra PC % Pkg B, InternationalACCUTRON, INC.BSZ2023-09-13
0081383002458656800 Chair Conversion KitACCUTRON, INC.BSZ2023-09-13
00813830027402Ultra PC % Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027419Ultra DC Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027426Digital Ultra Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027709Digital Ultra Flushmount Package G, INTACCUTRON, INC.BSZ2023-09-13
00813830028195Digital Ultra Package C, InternationalACCUTRON, INC.BSZ2023-09-13
00813830028522Digital Ultra Package F, UKACCUTRON, INC.BSZ2023-09-13
00816711023821Digital MDM, 30% Std ISOPARKER-HANNIFIN CORPORATIONBSZ2023-09-05