H3+

GUDID 00812345021684

Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder

Primary Device ID	00812345021684
NIH Device Record Key	53bcadd0-e978-4151-9911-ba75b515578b
Commercial Distribution Status	In Commercial Distribution
Brand Name	H3+
Version Model Number	H3PLUS-AAA-XXXXX
Company DUNS	062046149
Company Name	MORTARA INSTRUMENT, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 65 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00812345021684 [Primary]

MWJ	Electrocardiograph,Ambulatory(Without Analysis)

Steralize Prior To Use	false
Device Is Sterile	false