AccessGUDID - DEVICE: NxGen Peak Flow Meter (00860013746407)

GUDID

Device Identifier (DI) Information

Brand Name: NxGen Peak Flow Meter
Version or Model: 165253
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SAFEY MEDICAL DEVICES PRIVATE LIMITED

Primary DI Number: 00860013746407
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878291677 *Terms of Use

Device Description: NxGen Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects.

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?
46906	Expiratory peak flow meter, digital	A battery-powered, hand-held, electronic instrument designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. It typically includes a mouthpiece for patient exhalation and a digital display [e.g., liquid-crystal display (LCD)]; it may include a port for communicating with a computer/tablet. The device is typically intended to monitor the respiratory status of a patient affected by chronic respiratory disorders (e.g., asthma, emphysema) in a clinical setting or the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZH	Meter, Peak Flow, Spirometry

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200832	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
Handling Environment Temperature: between -10 and 70 Degrees Celsius
Handling Environment Atmospheric Pressure: between 75 and 100 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Weight: 300 Gram

Device Record Status

Public Device Record Key: 99be5486-3a37-4db1-9fb2-7d043d3f10ae
Public Version Date: March 31, 2025
Public Version Number: 2
DI Record Publish Date: January 27, 2025