FDA.reportPublic FDA data

Magellan 2200 Model - 3

Primary DI
00864604000367
Brand
Magellan 2200 Model - 3
Company
OCEANIC MEDICAL PRODUCTS, INC.
Model
1
Published
2017-04-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K072420000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072420000MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINEOceanic Medical Products, Inc.2008-01-22BSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864604000367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864604000367008646040003678646040003670864604000367

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia unit, mobileA stand-alone assembly of devices on wheels for mobility designed to continuously or intermittently administer a mixture of gases [e.g., oxygen (O2), ambient/medical air, nitrous oxide (N2O), anaesthetic agents] to provide a patient with an appropriate level of anaesthesia for a surgical procedure. Also known as an anaesthesia machine, it may include an oxygen concentrator or function with mounted medical gas cylinders, and typically has mechanical gas-delivery devices (e.g., flowmeters and vaporizers). It may incorporate a powered or manual anaesthesia ventilator, a patient breathing circuit, and gas monitoring devices; patient monitors are typically separately mounted (not integral).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796816515
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864604000305Magellan Ventilator 12016-10-21
00864604000312MaxO2Vent12016-10-21
00864604000329Magellan 2200 Model - 112016-10-21
00864604000336Magellan 2200 Model - 212016-10-21
00864604000343Magellan 2200 Model - 312016-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814905021400Codonics Safe Label System®(SLS) 610i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021417Codonics Safe Label System®(SLS) 620i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
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
00852087007898Infinium Medical Inc.INFINIUM MEDICAL, INC.BSZ2024-05-06
00816711024439DIGITAL MDM ASSY-120V(STAND MTPARKER-HANNIFIN CORPORATIONBSZ2024-04-05
00813830026979FRU, Gauge Newport O2ACCUTRON, INC.BSZ2023-10-05
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