AccessGUDID - DEVICE: InHealth Technologies; Blom-Singer (00848253000961)

GUDID

Device Identifier (DI) Information

Brand Name: InHealth Technologies; Blom-Singer
Version or Model: FM 1005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Freudenberg Medical, LLC

Primary DI Number: 00848253000961
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
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?
61420	Hypopharyngeal fistula occluder	A device intended to be used for the non-surgical short-term (i.e., < 30 days) occlusion of a fistula in the upper end of the oesophagus (hypopharynx), typically where the fistula has an external opening, to prevent leakage of oesophageal content. It consists of two disk-like flanges (one being positioned on the inside of the pharynx and one on the outside) attached to a single- or double-beaded stem, and is made of silicone and plastic materials. It is inserted and removed using a dedicated device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	Instrument, Ent Manual Surgical

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: 3ca861b5-2632-430c-a6d4-cc3ec2f8a683
Public Version Date: February 19, 2021
Public Version Number: 3
DI Record Publish Date: January 01, 2017