AccessGUDID - DEVICE: InHealth Technologies; Blom-Singer (00813307011514)

GUDID

Device Identifier (DI) Information

Brand Name: InHealth Technologies; Blom-Singer
Version or Model: IN 4050
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Freudenberg Medical, LLC

Primary DI Number: 00813307011514
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 120981337 *Terms of Use

Device Description: No description.

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?
62096	Tracheoesophageal speech valve irrigation device	A non-sterile hand-held device intended to be used for the in situ washing of an indwelling tracheoesophageal speech valve by water irrigation to remove organic matter (e.g., phlegm). It is in the form of a water-fillable squeeze bulb with a distal nozzle that is inserted through the tracheostoma into the central lumen of the valve; it is intended to be used routinely by a patient in the home. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWL	Prosthesis, Laryngeal (Taub)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 61c17ba8-90ce-4870-b8e0-6044ac06c3c9
Public Version Date: September 25, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2016