FDA.reportPublic FDA data

Kryo ART Freezer

Primary DI
B199GDKRYOART171150
Brand
Kryo ART Freezer
Company
PLANER LIMITED
Model
GDKRYOART-1.7-115
Device description
Kryo ART Freezer System. 1.7 Litre Chamber
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MQGAccessory, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQGAccessory, Assisted ReproductionObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B199GDKRYOART171150PrimaryHIBCC0

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.

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

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
B199GDCT37M30CT37 IncubatorGDCT37-M-3 2018-04-03
B199GDCT37M3CO20CT37 IncubatorGDCT37-M-3-CO22018-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04779041940229Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABMQG2026-01-15
04779041940298MIRI Time-Lapse IncubatorESCO MEDICAL TECHNOLOGIES UABMQG2026-01-14
06975183900185Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.MQG2025-09-30
06975183900192Time-lapse Incubator Capacity Expansion ModuleHua Yue Medical Technology Co., Ltd.MQG2025-09-30
05060554120024CODARESEARCH INSTRUMENTS LIMITEDMQG2024-09-20
16975737430110MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
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06975737430106MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
26975737430001MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
00370275091011FS DispenserForward Science Technologies LLCMQG2024-02-21
05055270911643RocketROCKET MEDICAL PLCMQG2023-11-03
05055270984524RocketROCKET MEDICAL PLCMQG2023-10-31
05055270909060RocketROCKET MEDICAL PLCMQG2023-10-30
05055270909329RocketROCKET MEDICAL PLCMQG2023-10-30
05055270984463RocketROCKET MEDICAL PLCMQG2023-10-30
05055270911582RocketROCKET MEDICAL PLCMQG2023-10-24
00827002444294COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MQG2023-08-15
03661532000318STERILE 0.5 ML CBS STRAW FOR SPERM WITH COTTON PLUG / 4x5CRYO BIO SYSTEMMQG2020-11-03
03661532000349STERILE CBS 0.5 ML STRAW FOR SPERM WITH RED COTTON PLUG / 5 x20CRYO BIO SYSTEMMQG2020-11-03
03661532000356STERILE CBS 0.5 ML STRAW FOR SPERM WITH YELLOW COTTON PLUG / 5 X 20CRYO BIO SYSTEMMQG2020-11-03
03661532000363STERILE CBS 0.5 ML STRAW FOR SPERM WITH GREEN COTTON PLUG / 5 X 20CRYO BIO SYSTEMMQG2020-11-03
03661532000370STERILE CBS 0.5 ML STRAW FOR SPERM WITH BLUE COTTON PLUG / 5 X 20CRYO BIO SYSTEMMQG2020-11-03
03661532000479STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND RED FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03
03661532000486STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND WHITE FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03
03661532000493STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND YELLOW FLEXIBLE ROD / BLISTER 5X1CRYO BIO SYSTEMMQG2020-11-03
03661532000509STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND BLUE FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03