FDA.reportPublic FDA data

CT37 Incubator

Primary DI
B199GDCT37M30
Brand
CT37 Incubator
Company
PLANER LIMITED
Model
GDCT37-M-3
Device description
CT37Stax Incubator
Published
2018-04-03
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
B199GDCT37M30PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
217190495
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B199GDKRYO3701150KryoGDKRYO370-1152024-10-22
B199GDKRYO370CH1150KryoGDKRYO370-CH-1152024-10-22
B199GDKRYO5701150KryoGDKRYO570-1152024-10-22
B199GDKRYO570ART1150KryoGDKRYO570ART-1152024-10-22
B199GDKRYO570ARTCH1150KryoGDKRYO570ART-CH-1152024-10-22
B199GDKRYO570CH1150KryoGDKRYO570-CH-1152024-10-22
B199GDKRYO36017115020KryoKRYO360-1.7-115-02GDKRYO360-1.7-115-022023-04-30
B199GDKRYO36033115020KryoKryo360-3.3-115-02GDKRYO360-3.3-115-022023-04-30
B199GDKRYO56016115020KryoKRYO560-16-115-02GDKRYO560-16-115-022023-04-30
B199GDMR75000KryoMR7-500GDMR7-5002023-04-30
B199GDMR75600KryoMR7-560GDMR7-5602023-04-30
B199GDMR70MR7 ControllerGDMR72022-02-28
B199GDBT3702CS0BT37BT37-02GDBT37-02-CS2020-07-01
B199GDBT3702WWCS0BT37BT37-02GDBT37-02-WW-CS2020-07-01
B199GDBT3701ORIGIO0BT37 IncubatorGDBT37-01-ORIGIO2016-09-23
B199GDBT37USORIGIO0BT37 IncubatorGDBT37-US-ORIGIO2016-09-23
B199GDBT37WWORIGIO0BT37 Incubator GDBT37-WW-ORIGIO2016-09-23
B199GDCT37M0CT37 IncubatorGDCT37-M2018-04-03
B199GDCT37M3CO20CT37 IncubatorGDCT37-M-3-CO22018-04-03
B199GDCT37M40CT37 IncubatorGDCT37-M-4 2018-04-03

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
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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