AccessGUDID - DEVICE: FloSense (B279DP2507)

GUDID

Device Identifier (DI) Information

Brand Name: FloSense
Version or Model: Bidirectional
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DP250-7
Company Name: S D I DIAGNOSTICS INC

Primary DI Number: B279DP2507
Issuing Agency: HIBCC
Commercial Distribution End Date: July 31, 2019
Device Count: 25
Labeler D-U-N-S® Number*: 037690120 *Terms of Use

Device Description: FloSense Sensor

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:	Yes
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?
35282	Pulmonary function analysis system, adult	A device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAX	Pneumotachometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K990962	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: c75cdc2e-c272-4ce3-9fc8-0e3e3bb3962c
Public Version Date: August 26, 2019
Public Version Number: 4
DI Record Publish Date: September 09, 2016