AccessGUDID - DEVICE: InHealth Technologies; Blom-Singer; StomaSoft (00848253003337)

GUDID

Device Identifier (DI) Information

Brand Name: InHealth Technologies; Blom-Singer; StomaSoft
Version or Model: BE 6703F
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Freudenberg Medical, LLC

Primary DI Number: 00848253003337
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 120981337 *Terms of Use

Device Description: Laryngectomy Tube, 10/55mm, non-sterile, fenestrated

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):	Yes
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?
62136	Laryngectomy tube, non-sterile	A non-sterile hollow device intended to maintain tracheostoma patency after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis in the months following the procedure. It is a soft plastic or silicone curved tube, similar to a tracheostomy tube, contoured to fit the postoperative tracheal anatomy, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KAC	Tube, Laryngectomy

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 230c3cdd-2c09-48d3-8f12-9297633d5987
Public Version Date: June 17, 2019
Public Version Number: 1
DI Record Publish Date: June 07, 2019