AccessGUDID - DEVICE: InHealth Technologies; Blom-Singer® (00848253003115)

GUDID

Device Identifier (DI) Information

Brand Name: InHealth Technologies; Blom-Singer®
Version or Model: TP 2208-LEF
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Freudenberg Medical, LLC

Primary DI Number: 00848253003115
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 120981337 *Terms of Use

Device Description: Blom-Singer® FirstFit Surgical Kit with 22.5Fr Voice Prosthesis, 8mm length

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
36071	Tracheostomy tube speech valve	A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.	Active	false
65394	Tracheoesophageal speech valve guidewire	A hand-held flexible wire intended to assist surgical placement of an indwelling tracheoesophageal speech valve into a tracheoesophageal fistula (puncture). It incorporates a distal connector onto which the speech valve is attached prior to guidewire advancement through a tracheostoma or endoscope; it may in addition be used for the transoral removal of a tracheoesophageal speech valve before introducing its replacement. This is a single-use 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: Yes
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: e56623f1-1c03-4bec-84e0-30c4c9509076
Public Version Date: February 10, 2025
Public Version Number: 2
DI Record Publish Date: November 03, 2023