FDA.reportPublic FDA data

Mindray

Primary DI
06923980112546
Brand
Mindray
Company
GaleMed Xiamen Co., Ltd.
Model
XMR0066
Device description
Silicone breathing hose, adult, 0.45m
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
46923980112544PackageGS150In Commercial Distribution
06923980112546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4692398011254446923980112544
06923980112546069239801125466923980112546

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, reusableAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.

Regulatory Flags#

DUNS number
527333326
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
06923980112577MindrayXMR00242026-05-26
06923980112584MindrayXMR00262026-05-26
06923980112591MindrayXMR01012026-05-26
06923980112607MindrayXMR01022026-05-26
06923980112614MindrayXMR00522026-05-26
06923980112621MindrayXMR00532026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055146499122Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499146Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499467Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499474Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499481Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499498Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499634Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055147001393Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055147001409Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146040935Breathing set, unheatedWILAmed GmbHBZO2026-10-19
04048675826088VentStar Coax GSL 180Drägerwerk AG & Co. KGaABZO2026-10-15
04048675826316Anesthesia Set Coax GSL 180Drägerwerk AG & Co. KGaABZO2026-10-15
05404013001507ClassicPlastiflex GroupBZO2026-09-21
05404013001521ClassicPlastiflex GroupBZO2026-09-21
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14026704929204GIBECKTELEFLEX INCORPORATEDBZO2026-08-01
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00848530108854Breathing CircuitSunset Healthcare Solutions, Inc.BZO2026-05-12