AccessGUDID - DEVICE: Flosense II (B279S298040250)

GUDID

Device Identifier (DI) Information

Brand Name: Flosense II
Version or Model: II
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 29-8040-250
Company Name: S D I DIAGNOSTICS INC

Primary DI Number: B279S298040250
Issuing Agency: HIBCC
Commercial Distribution End Date: December 06, 2022
Device Count: 250
Labeler D-U-N-S® Number*: 037690120 *Terms of Use

Device Description: FloSense II

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?
44545	Breathing mouthpiece, single-use	A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZG	Spirometer, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033939	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: b8fa09e1-f4d6-4255-bba6-1ebf54e53a9b
Public Version Date: July 06, 2023
Public Version Number: 6
DI Record Publish Date: July 26, 2016