FDA.reportPublic FDA data

K-Systems

Primary DI
00888937025071
Brand
K-Systems
Company
Coopersurgical, Inc.
Model
K23054
Device description
T47 Warming Plate
Published
2020-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PUBAccessory, Assisted Reproduction, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUBAccessory, Assisted Reproduction, ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937025071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937025071008889370250718889370250710888937025071

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction heater/incubatorAn electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04779041940168Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940199Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940267Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940311MIRI Time-Lapse IncubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940809Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940816Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-15
04779041940243Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940465Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940472Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940496Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940502Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940519Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940526Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940533Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940540Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940557Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940564Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04779041940700Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-14
04580647510125EC10-120MDASTEC CO.,LTD.PUB2026-01-12
04779041940458Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-12
04779041940441Multi-zone ART WorkstationESCO MEDICAL TECHNOLOGIES UABPUB2026-01-07
06975183900062HARIOMEDHua Yue Medical Technology Co., Ltd.PUB2025-03-14
06975183900079HARIOMEDHua Yue Medical Technology Co., Ltd.PUB2025-03-14
06975183900086HARIOMEDHua Yue Medical Technology Co., Ltd.PUB2025-03-14
06975183900093HARIOMEDHua Yue Medical Technology Co., Ltd.PUB2025-03-14
05060554120956K-SystemsRESEARCH INSTRUMENTS LIMITEDPUB2025-02-25
05060554120963K-SystemsRESEARCH INSTRUMENTS LIMITEDPUB2025-02-25
00888937014488TITANRESEARCH INSTRUMENTS LIMITEDPUB2024-09-20
00888937014587MARSRESEARCH INSTRUMENTS LIMITEDPUB2024-09-20
00888937014600MARSRESEARCH INSTRUMENTS LIMITEDPUB2024-09-20