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 ID00073796907150
NIH Device Record Keyc87ae190-9a38-46aa-983e-b3f8f5538c53
Commercial Distribution StatusIn Commercial Distribution
Brand NameBattery Pack for HEM-907 and HEM-907XL
Version Model NumberHEM-907-PBAT
Catalog NumberHEM-907-PBAT
Company DUNS054318779
Company NameOmron Healthcare, Inc.
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796907150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

Devices Manufactured by Omron Healthcare, Inc.

10073796253605 - Gold Upper Arm Blood Pressure Monitor 2025-02-03 Gold Upper Arm Blood Pressure Monitor with Wide-Range D-Ring Cuff, 80 memory readings with blue tooth connectivity, 2 user modes
00073796254650 - Platinum Upper Arm Blood Pressure Monitor 2025-02-03 Platinum Upper Arm Blood Pressure Monitor with Wide-Range D-Ring Cuff, 100 memory readings with blue tooth connectivity, 2 user
00073796273606 - 7 Series Upper Arm Blood Pressure Monitor2025-01-08 7 Series Upper Arm Blood Pressure Monitor with Easy-Wrap ComFit Cuff, 60 memory readings, with blue tooth connectivity, 2 user m
00073796274658 - 10 Series Upper Arm Blood Pressure Monitor2025-01-08 10 Series Upper Arm Blood Pressure Monitor with Easy-Wrap ComFit Cuff, 100 memory readings, with blue tooth connectivity, 2 user
10073796250000 - Iron Upper Arm Blood Pressure Monitor2024-05-23 Upper Arm Blood pressure monitor, automatic inflation, wide range D-ring cuff 9"-17" inches.
10073796251502 - Bronze Upper Arm Blood Pressure Monitor2024-05-23 Upper Arm Blood Pressure Monitor Automatic Inflation with wide range cuff, and 14 memory readings.
10073796252554 - Silver Upper Arm Blood Pressure Monitor2024-05-23 Upper Arm Blood Pressure Monitor w/Bluetooth Connectivity, 30 Reading Memory, Easy Wrap ComFit Cuff
10073796271500 - 3 Series Upper Arm Blood Pressure Monitor2024-04-23 Automatic inflation upper arm blood pressure monitor with wide range cuff. (9-17 inch), Bluetooth connectivity, 14 memory storag

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.