Kryo 360 Freezer

GUDID B199GDKRYO36017115DT0

Kryo 360 Controlled Rate Freezer. 1.7 Litre Chamber

PLANER LIMITED

Freezer control unit, programmable Freezer control unit, programmable
Primary Device IDB199GDKRYO36017115DT0
NIH Device Record Key38d7ba17-43d6-4b06-807d-4c644fe7aa65
Commercial Distribution StatusIn Commercial Distribution
Brand NameKryo 360 Freezer
Version Model NumberGDKRYO360-1.7-115-DT
Company DUNS217190495
Company NamePLANER LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB199GDKRYO36017115DT0 [Primary]

FDA Product Code

KSPApparatus, Cell-Freezing And Reagents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-28
Device Publish Date2016-09-23

On-Brand Devices [Kryo 360 Freezer]

B199GDKRYO360CH331150Kryo 360 Controlled Rate Freezer. 3.3 litre Chamber Only
B199GDKRYO360CH171150Kryo 360 Controller Rate Freezer - 1.7 Chamber Only
B199GDKRYO36033115DT0Kryo 360 Controlled Rate Freezer. 3.3 Litre Chamber.
B199GDKRYO360331150Kryo 360 Controlled Rate Freezer. 3.3 Litre Chamber
B199GDKRYO36017115DT0Kryo 360 Controlled Rate Freezer. 1.7 Litre Chamber
B199GDKRYO360171150Kryo 360 Controlled Rate Freezer. 1.7 Litre Chamber

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.