CT37 Incubator

GUDID B199GDCT37M0

Assisted reproduction heater/incubator

Primary Device ID	B199GDCT37M0
NIH Device Record Key	31091919-6485-4da1-9303-f1ba082df34c
Commercial Distribution Status	In Commercial Distribution
Brand Name	CT37 Incubator
Version Model Number	GDCT37-M
Company DUNS	217190495
Company Name	PLANER LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	B199GDCT37M0 [Primary]

PUB	Accessory, Assisted Reproduction, Exempt

Steralize Prior To Use	false
Device Is Sterile	false