AccessGUDID - DEVICE: InHealth Technologies; Blom-Singer (00813307014737)

GUDID

Device Identifier (DI) Information

Brand Name: InHealth Technologies; Blom-Singer
Version or Model: IN 4065
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Freudenberg Medical, LLC

Primary DI Number: 00813307014737
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):	Yes
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?
62095	Airway device cleaning utensil, invasive	A non-sterile hand-held device intended to be used to clean an in situ airway device (e.g., indwelling tracheoesophageal speech valve, laryngeal airway). It is inserted into the central lumen of the device and typically rotated multiple times to remove organic matter (e.g., phlegm); it may also be used to clean an airway device ex situ (i.e., once it has been removed from the patient). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EPE	Brush, Cleaning, Tracheal Tube

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: d8852ed3-af5c-418e-92cb-abca8a049aeb
Public Version Date: September 25, 2020
Public Version Number: 4
DI Record Publish Date: January 01, 2017