AccessGUDID - DEVICE: Nihon Kohden (00843685100173)

GUDID

Device Identifier (DI) Information

Brand Name: Nihon Kohden
Version or Model: MSK3316P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MSK3316P
Company Name: NIHON KOHDEN ORANGEMED, INC.

Primary DI Number: 00843685100173
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079962037 *Terms of Use

Device Description: The NPPV cap-ONE Mask Set (Extra Small) is used with the TG-980P CO2 sensor kit. The Mask Set covers the patient nose and mouth and connects to the breathing circuit of the ventilator to monitor expiratory CO2 partial pressure and provide gas from the ventilator to the patient.

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:	Yes
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?
57813	CPAP/BPAP face mask, single-use	A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNT	Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213521	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 65 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1d90934b-828e-4048-9f1f-80eaf9cb7658
Public Version Date: October 19, 2022
Public Version Number: 1
DI Record Publish Date: October 11, 2022