AccessGUDID - DEVICE: NxGen Pocket Spirometer (00860013746414)

GUDID

Device Identifier (DI) Information

Brand Name: NxGen Pocket Spirometer
Version or Model: 165221
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SAFEY MEDICAL DEVICES PRIVATE LIMITED

Primary DI Number: 00860013746414
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878291677 *Terms of Use

Device Description: NxGen Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Phone to carry out tests. NxGen Pocket Spirometer is intended to be used by patients above 5 years of age to perform basic lung function tests under the instruction of a physician or practitioner licensed by law to measure the health of the lung. Pocket Spirometer is intended to be used under Home Healthcare environment.

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?
13680	Diagnostic spirometer, professional	An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZG	Spirometer, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201002	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 Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 70 Degrees Celsius
Handling Environment Atmospheric Pressure: between 75 and 100 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Weight: 300 Gram

Device Record Status

Public Device Record Key: 5e028e59-5191-4653-8ca3-914c2fe4b1f9
Public Version Date: March 31, 2025
Public Version Number: 2
DI Record Publish Date: January 27, 2025