FDA.reportPublic FDA data

Somnostar

Primary DI
10846446033298
Brand
Somnostar
Company
Carefusion Corporation
Model
29675-001
Catalog number
29675-001
Device description
SOMNOSTAR 11 UPGRADE
Published
2016-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846446033298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084644603329810846446033298

GMDN Terms#

Term, Definition table
TermDefinition
Desktop computerA non-dedicated mains electricity (AC-powered) computer designed to be stationary on a desk or other work platform. It includes hardware components [e.g., central processing unit (CPU)], and is used in conjunction with a monitor, keyboard, and mouse.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.231.2466support.sleep.us@carefusion.com

Regulatory Flags#

DUNS number
830432451
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403296864enFlow980304VS30980304VS302016-09-21
10846446001693Vela11571115712017-06-23
10885403272424AirLife6098ADPG6098ADPG2016-09-01
10885403272431AirLife6098DPG6098DPG2016-09-01
10885403001024AirLife5007P5007P2016-09-01
10885403006425AirLife0020020020022016-09-01
10885403006524AirLife0024300024302016-09-01
10885403006531AirLife0024310024312016-09-01
10885403006548AirLife0024330024332016-09-01
10885403006555AirLife0024340024342016-09-01
10885403006562AirLife0024350024352016-09-01
10885403006579AirLife0024380024382016-09-21
10885403006586AirLife0024430024432016-09-01
10885403006593AirLife0024440024442016-09-01
10885403010958AirLife0024460024462016-09-01
10885403010996AirLife0025010025012016-09-01
10885403011726AirLife0016180016182016-09-01
10885403026980AirLife6200-5046200-5042016-09-01
10885403027079AirLife6934-5046934-5042016-09-01
10885403039072AirLife0021730021732016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08720256698302Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.OLV2026-05-15
08720256698326Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.OLV2026-05-15
08720256698357Onera STS 2Onera B.V.OLV2026-05-15
08720256698364Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.OLV2026-05-15
08720256698463Onera STSOnera B.V.OLV2026-05-15
08720256698487Onera STSOnera B.V.OLV2026-05-15
08720256698494Onera STSOnera B.V.OLV2026-05-15
08720256698500Onera STSOnera B.V.OLV2026-05-15
08720256698517Onera STSOnera B.V.OLV2026-05-15
08720256698524Onera STSOnera B.V.OLV2026-05-15
08720256698531Onera STSOnera B.V.OLV2026-05-15
00850049266055WavebandBeacon Biosignals, Inc.OLV2026-04-17
00850049266062WavebandBeacon Biosignals, Inc.OLV2026-04-17
B566847020ZmachineGeneral SleepOLV2026-04-16
B566847001ZmachineGeneral SleepOLV2026-04-09
B566847002ZmachineGeneral SleepOLV2026-04-09
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDOLV2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDOLV2026-03-12
00840067104224CadwellCADWELL INDUSTRIES, INC.OLV2026-03-02
00840067104217CadwellCADWELL INDUSTRIES, INC.OLV2026-03-01
00850063034364Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2025-12-22
00817111021332PolysmithNeurotronics, LLCOLV2025-09-23
00850063034128Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2025-01-28
00850063034142Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2025-01-28
00850063034159Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2025-01-28