AccessGUDID - DEVICE: Nihon Kohden (00843685100036)

GUDID

Device Identifier (DI) Information

Brand Name: Nihon Kohden
Version or Model: DSP5500A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DSP5500A
Company Name: NIHON KOHDEN ORANGEMED, INC.

Primary DI Number: 00843685100036
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079962037 *Terms of Use

Device Description: The Nihon Kohden Graphic User Interface is a display that is used with all NKV-550 Ventilator configurations. The Graphical User Interface may be provided to users as a replacement or as a second Graphical User Interface.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
42411	Neonatal/adult intensive-care ventilator	A mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBK	Ventilator, Continuous, Facility Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181695	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 Atmospheric Pressure: between 50 and 106 KiloPascal
Special Storage Condition, Specify: Altitude: 6096 meters (maximum)
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fb5e412b-3640-4dc5-988f-8d5211518235
Public Version Date: June 06, 2023
Public Version Number: 2
DI Record Publish Date: March 27, 2020