AccessGUDID - DEVICE: Battery Pack for HEM-907 and HEM-907XL (00073796907150)

GUDID

Device Identifier (DI) Information

Brand Name: Battery Pack for HEM-907 and HEM-907XL
Version or Model: HEM-907-PBAT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HEM-907-PBAT
Company Name: Omron Healthcare, Inc.

Primary DI Number: 00073796907150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 054318779 *Terms of Use

Device Description: Battery Pack for HEM-907 and HEM-907XL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032305	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c87ae190-9a38-46aa-983e-b3f8f5538c53
Public Version Date: May 03, 2023
Public Version Number: 5
DI Record Publish Date: September 16, 2016