FDA.reportPublic FDA data

Magellan Ventilator

Primary DI
00864604000305
Brand
Magellan Ventilator
Company
OCEANIC MEDICAL PRODUCTS, INC.
Model
1
Published
2016-10-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002951000MAGELLAN VENTILATOROceanic Medical Products, Inc.2000-12-08CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864604000305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864604000305008646040003058646040003050864604000305

GMDN Terms#

Term, Definition table
TermDefinition
Portable pneumatic ventilatorA pneumatically-powered, lightweight device that is easily moved/mounted and used to provide long-term alveolar ventilation support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through an endotracheal (ET) tube, tracheostomy cannula, or mask. It includes a control system and alarms, sometimes with additional features (e.g., humidification). Several methods of cycling and ventilation modes may be used. It is typically used in the home, but may also be used in an extended care facility, and/or by emergency medical services (EMS).

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
00864604000312MaxO2Vent12016-10-21
00864604000329Magellan 2200 Model - 112016-10-21
00864604000336Magellan 2200 Model - 212016-10-21
00864604000343Magellan 2200 Model - 312016-10-21
00864604000367Magellan 2200 Model - 312017-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102679MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676247DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676254DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676261DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676377DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676384DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676391DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676407DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676360DIMARHMC PREMEDICAL SPACBK2025-03-20
10889483603987AirLife™AIRLIFECBK2025-02-26
10889483603994AirLife™AIRLIFECBK2025-02-26
10889483604007AirLife™AIRLIFECBK2025-02-26
10889483604045AirLife™AIRLIFECBK2025-02-26
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10889483604069AirLife™AIRLIFECBK2025-02-26
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10889483604083AirLife™AIRLIFECBK2025-02-26
10889483604090AirLife™AIRLIFECBK2025-02-26