FDA.reportPublic FDA data

K-Systems

Primary DI
00888937023947
Brand
K-Systems
Company
Coopersurgical, Inc.
Model
6.122.212.121
Device description
L126 IVF, Standard Heat Left, Monitor
Published
2020-05-12
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
00888937023947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937023947008889370239478889370239470888937023947

GMDN Terms#

Term, Definition table
TermDefinition
Laminar airflow hoodA ventilated laboratory enclosure designed to prevent airborne biological contamination of laboratory specimens contained within, and personnel handling the specimen, by creating a barrier with a forced flow of uniform-velocity and parallel-direction air. It is typically a plastic/metallic cabinet-like structure with an open front for product handling and a sash to regulate the opening. Air is typically drawn from the environment into the system by negative pressure created by a line-powered blower; air particles and liquid droplets are removed usually using high-efficiency particulate air (HEPA) filters. Contaminated air is usually exhausted to the outside; also known as an LAF bench.

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
00888937028508LifeGlobal® MediaH5TF-010MH5TF-010M2026-05-11
00888937028515LifeGlobal® MediaH5TF-050MH5TF-050M2026-05-11
00888937028522LifeGlobal® MediaH5TF-100MH5TF-100M2026-05-11
00888937028539LifeGlobal® MediaLGGF-050MLGGF-050M2026-05-11
00888937028546LifeGlobal® MediaLGGF-100MLGGF-100M2026-05-11
00888937028614LifeGlobal® MediaGCOL-100MGCOL-100M2026-05-11
00888937028621LifeGlobal® MediaGCOL-500MGCOL-500M2026-05-11
00888937028638LifeGlobal® MediaLGOL-100MLGOL-100M2026-05-11
00888937028645LifeGlobal® MediaLGOL-500MLGOL-500M2026-05-11
00888937028652LifeGlobal® MediaAMLO-100MAMLO-100M2026-05-11
00888937028669LifeGlobal® MediaLGPO-100MLGPO-100M2026-05-11
00888937028676LifeGlobal® MediaLGPO-500MLGPO-500M2026-05-11
00888937028683LifeGlobal® MediaAMPO-100MAMPO-100M2026-05-11
00888937028690LifeGlobal® MediaLGUA-100MLGUA-100M2026-05-11
00888937028706LifeGlobal® MediaLGUA-500MLGUA-500M2026-05-11
00888937028713LifeGlobal® MediaAMLG-100MAMLG-100M2026-05-11
00888937028935LifeGlobal® MediaH5TH-050MH5TH-050M2026-05-11
00888937028942LifeGlobal® MediaH5TH-100MH5TH-100M2026-05-11
00888937029017LifeGlobal® MediaLGGH-050MLGGH-050M2026-05-11
00888937029024LifeGlobal® MediaLGGH-100MLGGH-100M2026-05-11

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