AccessGUDID - DEVICE: CAIRE Diagnostics (00860008017949)

GUDID

Device Identifier (DI) Information

Brand Name: CAIRE Diagnostics
Version or Model: Fenom Pro, Australia/New Zealand
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900-0012
Company Name: Caire Diagnostics Inc.

Primary DI Number: 00860008017949
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117548764 *Terms of Use

Device Description: Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for Australia/New Zealand AC Power Cord Cable, Australia/New Zealand - PN 415-0010

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):	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
MXA	System, Test, Breath Nitric Oxide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182874	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: 2c3d9856-3ca0-4711-bc16-6a7fa1611a6a
Public Version Date: March 08, 2022
Public Version Number: 2
DI Record Publish Date: January 31, 2022