Battery Pack for HEM-907 and HEM-907XL HEM-907-PBAT

GUDID 00073796907150

Battery Pack for HEM-907 and HEM-907XL

Omron Healthcare, Inc.

Rechargeable battery pack

Primary Device ID	00073796907150
NIH Device Record Key	c87ae190-9a38-46aa-983e-b3f8f5538c53
Commercial Distribution Status	In Commercial Distribution
Brand Name	Battery Pack for HEM-907 and HEM-907XL
Version Model Number	HEM-907-PBAT
Catalog Number	HEM-907-PBAT
Company DUNS	054318779
Company Name	Omron Healthcare, 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	true
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	true

Customer Support Contacts

Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com
Phone	1-800-634-4350
Email	ohiquality@omron.com

Operating and Storage Conditions

Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Humidity	Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment Humidity	Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796907150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K032305

FDA Product Code

DXN	System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-16

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