FDA.reportPublic FDA data

A7 Multi Gas Module with Accessory Kit

Primary DI
06944904084251
Brand
A7 Multi Gas Module with Accessory Kit
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
115-016575-00
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSZGas-machine, anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSZGas-Machine, AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151954000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151954000A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-10-27BSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944904084251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944904084251069449040842516944904084251

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, multiple-gasA small unit dedicated to the measurement of various gas concentrations, e.g., anaesthetic agents, oxygen (O2), carbon dioxide (CO2), in inspired and expired air obtained through a sampling tube connected to a main respiratory channel (mainstream) or a side-channel (sidestream) of a breathing circuit. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot and the parent device then operates as a mainframe computer displaying the parameters measured and provided by this module.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8675581888998service@mindray.com.cn

Regulatory Flags#

DUNS number
654671304
Device count
1
Kit
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06903053124348Diagnostic Ultrasound SystemMU9 Pro2026-06-03
06903053124355Diagnostic Ultrasound SystemMU9A2026-06-03
06903053124379Diagnostic Ultrasound SystemMU7 Pro2026-06-03
06903053124430Diagnostic Ultrasound SystemMU9 Super2026-06-03
06903053124461Diagnostic Ultrasound SystemMU72026-06-03
06903053124492Diagnostic Ultrasound SystemMU7 Super2026-06-03
06903053124546Diagnostic Ultrasound SystemMU9S2026-06-03
06903053124560Diagnostic Ultrasound SystemMU9P2026-06-03
06903053124591Diagnostic Ultrasound SystemMU92026-06-03
06903053124607Diagnostic Ultrasound SystemMU7S2026-06-03
06903053124614Diagnostic Ultrasound SystemMU7A2026-06-03
06903053124683Diagnostic Ultrasound SystemMU9T2026-06-03
06903053124706Diagnostic Ultrasound SystemMU7T2026-06-03
06903053124720Diagnostic Ultrasound SystemMU7P2026-06-03
06903053124775Diagnostic Ultrasound SystemMU9 Exp2026-06-03
06903053124829Diagnostic Ultrasound SystemMU7 Exp2026-06-03
06936415904661MR Na/K Check Solution105-011386-002026-01-23
06936415904678MR Detergent Solution105-011383-002026-01-23
06936415904685MR Buffer Solution105-011382-002026-01-23
06944904084459Chemistry AnalyzerCLC720i2026-01-23

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Primary DI, Brand, Company table
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00814905021431Codonics Safe Label System®(SLS) 630i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
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00813830026986FRU, Gauge Newport N2OACCUTRON, INC.BSZ2023-09-15
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00813830027419Ultra DC Package C ADJSACCUTRON, INC.BSZ2023-09-13
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00813830027709Digital Ultra Flushmount Package G, INTACCUTRON, INC.BSZ2023-09-13
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