AccessGUDID - DEVICE: Hobbs Achalasia Dilation Balloon (M84933040)

GUDID

Device Identifier (DI) Information

Brand Name: Hobbs Achalasia Dilation Balloon
Version or Model: 3304
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3304
Company Name: HOBBS MEDICAL, INC.

Primary DI Number: M84933040
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076769355 *Terms of Use

Device Description: A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestinal strictures of the lower esophageal schinctor. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen and wire-guided. This is a single-use device.

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":	Yes
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?
34915	Oesophageal balloon catheter	A long, flexible device with an inflatable balloon(s) at its distal end designed to access the length of the oesophagus of adult and adolescent patients to dilate strictures through balloon inflation. It is typically constructed as a catheter of various designs and is usually used endoscopically to enable visualization during the procedure. It is typically used to dilate strictures due to oesophageal surgery, primary gastric reflux, radiation therapy, and dilatation of the cardia in patients with achalasia (failure to relax the lower oesophageal sphincter). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KNQ	Dilator, Esophageal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K834413	000

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: d48e3c4e-cc8e-43dc-82ed-fe7aaa71c56c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016