FDA.reportPublic FDA data

GaleMed

Primary DI
04710810084126
Brand
GaleMed
Company
GaleMed Xiamen Co., Ltd.
Model
71050
Device description
CV-3 Single Limb Manifold
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
BXOTransducer, Gas Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXOTransducer, Gas PressureAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44710810084124PackageGS12In Commercial Distribution
04710810084126PrimaryGS10
94710810084129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4471081008412444710810084124
04710810084126047108100841264710810084126
9471081008412994710810084129

GMDN Terms#

Term, Definition table
TermDefinition
Air/gas pressure transducerA noninvasive electronic device designed to convert air or gas pressure signals into electrical signals for subsequent display or processing by a parent device (e.g., physiological data recorder, gastrointestinal motility analysis system). It may be a compact unit or included in an electrical cable, and receives pressure signals from connected pressure-measuring devices (e.g., urodynamic air-charged catheter, monitoring respiratory tubing).

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527333326
Device count
100
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
06923980111907MindrayXMR00512026-05-26
06923980112546MindrayXMR00662026-05-26
06923980112577MindrayXMR00242026-05-26
06923980112584MindrayXMR00262026-05-26
06923980112591MindrayXMR01012026-05-26
06923980112607MindrayXMR01022026-05-26
06923980112614MindrayXMR00522026-05-26
06923980112621MindrayXMR00532026-05-26
06923980112638MindrayXMR00812026-05-26
06923980112690MindrayXMR01042026-05-26
06923980112799MindrayXMR00582026-05-26
06923980112805MindrayXMR00442026-05-26
06923980112829MindrayXMR00462026-05-26
06944904007236MindrayXMR00862026-05-26
16923980111843MindrayXMR02302026-05-26
06923980112522MindrayXMR00112026-05-25
06923980112539MindrayXMR00122026-05-25
06923980112553MindrayXMR00212026-05-25
06923980112560MindrayXMR00232026-05-25
06923980112645MindrayXMR00152026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050863025MEDPAKLIFEPORT, LLCBXO2024-12-02
00813830024371Transducer, Guardian II Replacement KitACCUTRON, INC.BXO2023-09-13
00813830027235FRU, Pressure Transducer, 0-100 PSIACCUTRON, INC.BXO2023-09-13
00813830027242FRU, Pressure Transducer, 0-100 PSI, NPTACCUTRON, INC.BXO2023-09-13
00810050862417MedPakLIFEPORT, LLCBXO2023-05-24
00810050862387MedPakLIFEPORT, LLCBXO2023-03-27
00810050862042MedPakLIFEPORT, LLCBXO2022-06-28
00810050861878Patient Loading Utility System (PLUS)LIFEPORT, LLCBXO2022-02-04
00810050861793Patient Loading Utility System (PLUS)LIFEPORT, LLCBXO2022-01-07
00810050861687MedPakLIFEPORT, LLCBXO2021-10-28
00810050861533Patient Loading Utility System (PLUS)LIFEPORT, LLCBXO2021-07-21
00810050860710PLUSLIFEPORT, LLCBXO2021-01-05
00810050860727PLUSLIFEPORT, LLCBXO2021-01-05
10190752143838N/AAirLife Finland OyBXO2020-12-15
20190752143835N/AVyaire Medical OyBXO2020-12-15
00810050860475PLUSLIFEPORT, LLCBXO2020-09-18
00810050860192MedPakLIFEPORT, LLCBXO2020-07-07