FDA.reportPublic FDA data

GaleMed

Primary DI
04710810085161
Brand
GaleMed
Company
GaleMed Xiamen Co., Ltd.
Model
71024
Device description
Disposable Tee Valve
Published
2015-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BZAConnector, Airway (Extension)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44710810085169PackageGS1100In Commercial Distribution
04710810085161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4471081008516944710810085169
04710810085161047108100851614710810085161

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing valve, single-useA non-sterile device containing a one-way valve intended to be used to direct the flow of breathing gases, typically in a breathing circuit or between an oxygen mask and its reservoir bag, to prevent patient rebreathing of exhaled gases. The device is available in various designs and includes unidirectional valves made of various materials (e.g., silicone, rubber, metal, or mica sheets/discs) that typically open and close with each inspiration/expiration. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
527333326
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923980102776N/AAO00932026-09-22
06923980102783N/AAO00942026-09-22
06923980106026N/AAO00922026-09-22
06923980116179N/AAB05092026-08-19
06923980116186N/AAB05102026-08-19
06923980116193N/AAB05112026-08-19
06923980116209N/AAB05122026-08-19
06923980101922N/AAW0005AW00052023-08-16
06923980101939N/AAW0006AW00062023-08-16
06923980102028N/AAW0007AW00072023-08-16
06923980103629N/AAC01352026-07-28
06923980107672N/AAC01422026-07-28
06923980111969N/AAC01602026-07-28
06923980111907MindrayXMR00512026-05-26
06923980112546MindrayXMR00662026-05-26
06923980112577MindrayXMR00242026-05-26
06923980112584MindrayXMR00262026-05-26
06923980112591MindrayXMR01012026-05-26
06923980112607MindrayXMR01022026-05-26
06923980112614MindrayXMR00522026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109721OXYGEN CONNECTOR/ADAPTERSunset Healthcare Solutions, Inc.BZA2026-09-09
00848530109820Ventilation AccessorySunset Healthcare Solutions, Inc.BZA2026-09-09
00848530109837Ventilation AccessorySunset Healthcare Solutions, Inc.BZA2026-09-09
06923980103629N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
06923980107672N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
06923980111969N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
04719874957551Create BiotechCREATE BIOTECH CO., LTD.BZA2026-07-21
04719874959197Create BiotechCREATE BIOTECH CO., LTD.BZA2026-07-21
05055931133858Reusable Angle Connector for CBS Bag Arm – Male to MaleFLEXICARE MEDICAL LIMITEDBZA2026-07-21
05055931133865Reusable Angle Connector for CBS Bag Arm – Male to FemaleFLEXICARE MEDICAL LIMITEDBZA2026-07-21
10197344012039HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-07-06
10197344214792HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-05-18
10197344009800HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
10197344012008HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012435HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012466HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012596HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344042326HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012473HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-12-12
00848530107925Tracheostomy and SuctionSunset Healthcare Solutions, Inc.BZA2025-12-09
00848530098261VENTILATOR ACCESSORYSunset Healthcare Solutions, Inc.BZA2025-08-28
00848530107246Oxygen Connector/AdapterSunset Healthcare Solutions, Inc.BZA2025-08-19
10197344042432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-08-18
10884521854147DARCovidien LPBZA2025-08-10
00848530106317Ventilator CircuitSunset Healthcare Solutions, Inc.BZA2025-07-15
00848530106324Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530106331Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530106348Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530060299Oxygen Connector/AdapterSunset Healthcare Solutions, Inc.BZA2025-06-03
00848530097363Ventilator AccessorySunset Healthcare Solutions, Inc.BZA2025-05-21