AccessGUDID - DEVICE: InHealth Technologies; Blom-Singer (00848253003191)

GUDID

Device Identifier (DI) Information

Brand Name: InHealth Technologies; Blom-Singer
Version or Model: BE 3295
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Freudenberg Medical, LLC

Primary DI Number: 00848253003191
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 60
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:	Yes
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?
62134	Tracheoesophageal device insertion capsule	A non-sterile, smooth, capsule-like device intended to house/cover a tracheoesophageal device (e.g., speech valve, fistula gauge) at the distal end of the introduction assembly, to enable atraumatic insertion of the device into the tracheoesophageal fistula (puncture). It is a synthetic polymer gelatinous casing intended to dissolve in situ for subsequent digestion; disposable devices intended to assist mounting may be included. It is intended to be used in the home and healthcare facility, and may be used in conjunction with a lubricant. 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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry; Keep Away From Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 971706bc-47b4-4e00-838e-bb0558dbefbd
Public Version Date: April 02, 2018
Public Version Number: 1
DI Record Publish Date: March 01, 2018