FDA.report

Mindray

Primary DI
06944904007472
Brand
Mindray
Company
GaleMed Xiamen Co., Ltd.
Model
XMR0002
Device description
Gas Sampling Line, Neonate 2.5m
Published
2026-05-25
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
true

Related Records

Product Codes

CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications

CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06944904007472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06944904007472069449040074726944904007472

GMDN Terms

TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use 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
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
06923980112546MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-26
16923980111843MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-26
06923980112522MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-25
06923980112539MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-25
06944904007465MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-25
20197344011343HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
20197344011350HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
20197344011374HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
44710810100329N/AGALEMED CORPORATIONBZO2026-03-05
44710810107311N/AGALEMED CORPORATIONBZO2026-03-04
04719894389189VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
04719894389196VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
04719894389202VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
09420012479112F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479136F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479150F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479174F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
46923980106406N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
46923980106413N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
46923980106420N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
14719894389162VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-20
04719894389172VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-20
20889483225650AirLife™SUNMED, LLCBZO2025-12-19
44710810088405N/AGALEMED CORPORATIONBZO2025-12-18
14719894386314VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386321VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386338VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386345VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386352VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386369VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01