BT37 Incubator

GUDID B199GDBT37USORIGIO0

BT37 Benchtop Incubator.

PLANER LIMITED

Assisted reproduction heater/incubator
Primary Device IDB199GDBT37USORIGIO0
NIH Device Record Keyf55a5b13-1658-49a2-875f-f1b4b5cda08d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBT37 Incubator
Version Model NumberGDBT37-US-ORIGIO
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 Perscriptiontrue
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
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
HIBCCB199GDBT37USORIGIO0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2019-10-28
Device Publish Date2016-09-23

On-Brand Devices [BT37 Incubator]

B199GDBT37WWORIGIO0BT37 Benchtop Incubator
B199GDBT37USORIGIO0BT37 Benchtop Incubator.
B199GDBT3701ORIGIO0BT37 Benchtop Incubator - Origio

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