AccessGUDID - DEVICE: AincA® (B005001730)

GUDID

Device Identifier (DI) Information

Brand Name: AincA®
Version or Model: 00-173
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-173
Company Name: ANESTHESIA ASSOCIATES, INC.

Primary DI Number: B005001730
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002065670 *Terms of Use

Device Description: Peak Flow Meter, Std Mini-Wright, 60-800 lpm, SinglePatient, w/Mouthpiece (See 00-177/00-281)

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":	Yes
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?
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 [?]
K851265	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 973e63ca-f101-44ca-8d06-89f6f71c0d5c
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021