AccessGUDID - DEVICE: Omron Peak A-I-R Peak Flow Meter (00073796699406)

GUDID

Device Identifier (DI) Information

Brand Name: Omron Peak A-I-R Peak Flow Meter
Version or Model: PF9940
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PF9940
Company Name: Omron Healthcare, Inc.

Primary DI Number: 00073796699406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 054318779 *Terms of Use

Device Description: Peak Flow Meter for Adult / Pediatric

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?
46872	Peak flow meter, manual	A manual, hand-held instrument designed to measure only the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] from the lungs. It typically includes a tube for patient exhalation, an easy-to-grip handle, and a calibrated scale that shows the value of the peak flow. The device helps to discriminate the pulmonary status in routine tests performed in or outside of a clinical setting; it is also intended for periodic self-evaluation of the respiratory status of a patient, and to help in the treatment evaluation of patients suffering from chronic respiratory disorders (e.g., asthma, emphysema).	Obsolete	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982334	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 Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between -23 and 122 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Handling Environment Temperature: between 50 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aabe1e37-b4e3-4886-9043-7372ce8b1104
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 17, 2017