FDA.reportPublic FDA data

Kryo

Primary DI
B199GDKRYO570ART1150
Brand
Kryo
Company
PLANER LIMITED
Model
GDKRYO570ART-115
Device description
Kryo570ART Controlled Rate Freezer System
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KSPApparatus, Cell-Freezing And Reagents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSPApparatus, Cell-Freezing And ReagentsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B199GDKRYO570ART1150PrimaryHIBCC0

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
Serial number
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
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
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
B199GDKRYO3701150KryoPLANER LIMITEDKSP2024-10-22
B199GDKRYO370CH1150KryoPLANER LIMITEDKSP2024-10-22
B199GDKRYO5701150KryoPLANER LIMITEDKSP2024-10-22
B199GDKRYO570ARTCH1150KryoPLANER LIMITEDKSP2024-10-22
B199GDKRYO570CH1150KryoPLANER LIMITEDKSP2024-10-22
B199GDKRYO36017115020KryoPLANER LIMITEDKSP2023-04-30
B199GDKRYO36033115020KryoPLANER LIMITEDKSP2023-04-30
B199GDKRYO56016115020KryoPLANER LIMITEDKSP2023-04-30
B199GDMR75000KryoPLANER LIMITEDKSP2023-04-30
B199GDMR75600KryoPLANER LIMITEDKSP2023-04-30
B199GDMR70MR7 ControllerPLANER LIMITEDKSP2022-02-28
B199GDKRYO360171150Kryo 360 FreezerPLANER LIMITEDKSP2016-09-23
B199GDKRYO36017115DT0Kryo 360 FreezerPLANER LIMITEDKSP2016-09-23
B199GDKRYO360331150Kryo 360 FreezerPLANER LIMITEDKSP2016-09-23
B199GDKRYO36033115DT0Kryo 360 FreezerPLANER LIMITEDKSP2016-09-23
B199GDKRYO560161150Kryo 560 FreezerPLANER LIMITEDKSP2016-09-23
B199GDKRYO56016155DT0Kryo 560 FreezerPLANER LIMITEDKSP2016-09-23
B199GDKRYO750PLUSF1150Kryo 750 Freezer - Front LoaderPLANER LIMITEDKSP2016-09-23
B199GDKRYO750PLUST1150Kryo 750 Freezer - Top LoaderPLANER LIMITEDKSP2016-09-23
B199GDMRV0MRV ControllerPLANER LIMITEDKSP2016-09-23
B199GDMRVADAPTOR0MRV Controller AdaptorPLANER LIMITEDKSP2016-09-23
B199GDMRVADAPTORM0MRV Controller AdaptorPLANER LIMITEDKSP2016-09-23
B199GDMRVM0MRV ContollerPLANER LIMITEDKSP2016-09-23