AccessGUDID - DEVICE: Nihon Kohden Life Scope G5 Bedside Monitoring System (04931921023624)

GUDID

Device Identifier (DI) Information

Brand Name: Nihon Kohden Life Scope G5 Bedside Monitoring System
Version or Model: SB-950P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SB-950P
Company Name: NIHON KOHDEN CORPORATION

Primary DI Number: 04931921023624
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690568050 *Terms of Use

Device Description: Battery pack (for CU-151R, CU-152R)

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):	Yes
Over the Counter (OTC):	No
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
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 370f1f1d-5c90-45fe-b11a-81cd892a46b5
Public Version Date: April 15, 2024
Public Version Number: 4
DI Record Publish Date: September 27, 2021