CT37 Incubator

GUDID B199GDCT37M6CO20

CT37Stax Incubator

PLANER LIMITED

Assisted reproduction heater/incubator Assisted reproduction heater/incubator
Primary Device IDB199GDCT37M6CO20
NIH Device Record Key41f442ea-c847-483e-8cfd-3204f2350d81
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT37 Incubator
Version Model NumberGDCT37-M-6-CO2
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
HIBCCB199GDCT37M6CO20 [Primary]

FDA Product Code

PUBAccessory, Assisted Reproduction, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-28
Device Publish Date2018-04-03

On-Brand Devices [CT37 Incubator]

B199GDCT37M6CO20CT37Stax Incubator
B199GDCT37M60CT37Stax Incubator
B199GDCT37M5CO20CT37stax Incubator
B199GDCT37M50CT37Stax Incubator
B199GDCT37M4CO20CT37Stax Incubator
B199GDCT37M40CT37Stax Incubator
B199GDCT37M3CO20CT37Stax Incubator
B199GDCT37M30CT37Stax Incubator
B199GDCT37M0CT37stax Incubator

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