Battery Pack for HEM-907 and HEM-907XL

Basic Information

• Brand Name: Battery Pack for HEM-907 and HEM-907XL
• Primary DI: 00073796907150
• Version / Model: HEM-907-PBAT
• Catalog Number: HEM-907-PBAT
• Company Name: Omron Healthcare, Inc.
• Labeler DUNS: 054318779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 5
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: c87ae190-9a38-46aa-983e-b3f8f5538c53

Device Description

Battery Pack for HEM-907 and HEM-907XL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36534	Portable/mobile rechargeable battery pack	A group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00073796907150	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K032305	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 122 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 45 – 85 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 45 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -4 – 122 Degrees Fahrenheit