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

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
06903053063852Diagnostic Ultrasound SystemImagyn A20 Exp2026-10-31
06903053063869Diagnostic Ultrasound SystemNuewa A20Q2026-10-31
06903053063876Diagnostic Ultrasound SystemNuewa A Lumi2026-10-31
06903053063883Diagnostic Ultrasound SystemNuewa A18W2026-10-31
06903053063890Diagnostic Ultrasound SystemNuewa A20 Exp2026-10-31
06903053063906Diagnostic Ultrasound SystemNuewa A20 Plus2026-10-31
06903053063913Diagnostic Ultrasound SystemNuewa A20 Elite2026-10-31
06903053063937Diagnostic Ultrasound SystemNuewa AR2026-10-31
06903053063944Diagnostic Ultrasound SystemNuewa A202026-10-31
06903053063951Diagnostic Ultrasound SystemNuewa A MS2026-10-31
06903053063968Diagnostic Ultrasound SystemImagyn A20S2026-10-31
06903053063975Diagnostic Ultrasound SystemNuewa A20S2026-10-31
06903053063982Diagnostic Ultrasound SystemNuewa A20 Premium2026-10-31
06903053064002Diagnostic Ultrasound SystemNuewa A20W2026-10-31
06903053064019Diagnostic Ultrasound SystemNuewa A20 Pro2026-10-31
06903053064026Diagnostic Ultrasound SystemNuewa A MV2026-10-31
06903053064033Diagnostic Ultrasound SystemImagyn A202026-10-31
06903053064040Diagnostic Ultrasound SystemNuewa A20T2026-10-31
06903053064057Diagnostic Ultrasound SystemNuewa A Elite2026-10-31
06903053064064Diagnostic Ultrasound SystemImagyn A20T2026-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00814905021417Codonics Safe Label System®(SLS) 620i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021431Codonics Safe Label System®(SLS) 630i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021455Codonics Safe Label System®(SLS) 700i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00816711020097ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEMPARKER-HANNIFIN CORPORATIONBSZ2025-09-24
00810085200130Ultra PC% Oral Surgery Package HACCUTRON, INC.BSZ2025-05-14
B510AM60001ADVANCED GAS-MACHINE ANESTHESIAADVANCED INSTRUMENTATIONS, INC.BSZ2025-02-07
05051977000857PenlonPENLON LTDBSZ2024-12-06
06936415980702A3 Anesthesia Delivery SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.BSZ2024-11-20
00852087007881Infinium Medical Inc.INFINIUM MEDICAL, INC.BSZ2024-05-06
00852087007898Infinium Medical Inc.INFINIUM MEDICAL, INC.BSZ2024-05-06
00816711024439DIGITAL MDM ASSY-120V(STAND MTPARKER-HANNIFIN CORPORATIONBSZ2024-04-05
00813830026979FRU, Gauge Newport O2ACCUTRON, INC.BSZ2023-10-05
00813830021141Flowmeter, CMACCUTRON, INC.BSZ2023-09-21
00813830027785Flowmeter, Digital FlushMount, INTACCUTRON, INC.BSZ2023-09-21
04048675556169Atlan A300 XLDrägerwerk AG & Co. KGaABSZ2023-09-21
04048675556176Atlan A350Drägerwerk AG & Co. KGaABSZ2023-09-21
04048675556183Atlan A350 XLDrägerwerk AG & Co. KGaABSZ2023-09-21
04048675556343Atlan A300Drägerwerk AG & Co. KGaABSZ2023-09-21
00813830026986FRU, Gauge Newport N2OACCUTRON, INC.BSZ2023-09-15
00813830026993FRU, Gauge Newport Int O2ACCUTRON, INC.BSZ2023-09-15
00813830024579Chair Conversion KitACCUTRON, INC.BSZ2023-09-14
00813830023626Ultra PC % Pkg B, InternationalACCUTRON, INC.BSZ2023-09-13
0081383002458656800 Chair Conversion KitACCUTRON, INC.BSZ2023-09-13
00813830027402Ultra PC % Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027419Ultra DC Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027426Digital Ultra Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027709Digital Ultra Flushmount Package G, INTACCUTRON, INC.BSZ2023-09-13