AccessGUDID - DEVICE: Midmark Digital Spirometer w/Calibration Syringe (00841709107931)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark Digital Spirometer w/Calibration Syringe
Version or Model: 4-000-0028
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4-000-0028
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709107931
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: The Midmark Digital Spirometer is intended for prescription-use only by physicians and professional medical personnel to conduct diagnostic spirometry testing of adults and pediatric patients, 5 years and older, in hospitals and physician/clinician offices. Kit contains: digital spirometer, 10 single mouthpieces, one (1) ten pack of nose clips, calibration syringe.

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:	Yes
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 [?]
K002499	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 50 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4580bfda-a050-4291-96a5-67381b6ffe50
Public Version Date: March 08, 2022
Public Version Number: 3
DI Record Publish Date: June 02, 2020