FDA.reportPublic FDA data

BT37

Primary DI
B199GDBT3702WWCS0
Brand
BT37
Company
PLANER LIMITED
Model
BT37-02
Catalog number
GDBT37-02-WW-CS
Device description
BT37 Mark 2, Benchtop Incubator. Worldwide
Published
2020-07-01
Public version status
New
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
B199GDBT3702WWCS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction freezerA mains electricity (AC-powered) device designed to provide suitable cold storage conditions for reproductive biological materials (e.g., gametes, embryos) at closely regulated and monitored temperatures. It will typically use liquid nitrogen (LN2) to create cold temperatures, as well as an electrical heater and air circulating fan for temperature control. It will typically have an integral alarm system to warn against temperature variations and breaks in the mains power supply. This device is typically not intended for long-term storage.

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
B199GDBT3701ORIGIO0BT37 IncubatorGDBT37-01-ORIGIO2016-09-23
B199GDBT37USORIGIO0BT37 IncubatorGDBT37-US-ORIGIO2016-09-23
B199GDBT37WWORIGIO0BT37 Incubator GDBT37-WW-ORIGIO2016-09-23
B199GDCT37M0CT37 IncubatorGDCT37-M2018-04-03
B199GDCT37M30CT37 IncubatorGDCT37-M-3 2018-04-03
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
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