Kryo ART Freezer

GUDID B199GDKRYOARTCH171150

Kryo ART Controlled Rate Freezer. 1.7 litre Chamber Only

PLANER LIMITED

Assisted reproduction freezer
Primary Device IDB199GDKRYOARTCH171150
NIH Device Record Key77d48219-6a2e-44ba-9c67-59aa77cb848a
Commercial Distribution Discontinuation2017-09-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameKryo ART Freezer
Version Model NumberGDKRYOARTCH-1.7-115
Company DUNS217190495
Company NamePLANER LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB199GDKRYOARTCH171150 [Primary]

FDA Product Code

MQGAccessory, Assisted Reproduction

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 ART Freezer]

B199GDKRYOARTCH331150Kryo ART Controlled Rate Freezer. 3.3 litre Chamber Only
B199GDKRYOARTCH171150Kryo ART Controlled Rate Freezer. 1.7 litre Chamber Only
B199GDKRYOARTCH161150Kryo ART Controlled Rate Freezer. 16 litre Chamber Only
B199GDKRYOART331150Kryo ART Freezer System. 3.3 Litre Chamber
B199GDKRYOART171150Kryo ART Freezer System. 1.7 Litre Chamber
B199GDKRYOART161150Kryo ART Controlled Rate Freezer System. 16 Litre Chamber

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