AccessGUDID - DEVICE: NA (06932503523059)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MBD-BL-BA-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MBD-BL-BA-2
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503523059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: the balloon diameter is 8-9-10mm,the balloon length is 80mm,the catheter diameter is 7 Fr., and the working length is 1800mm,with stainless steel guide wire

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
17781	Rectosphincteric balloon	A hollow rubber structure, expandable with either liquid or air, used in conjunction with a manometer to assess anorectal function (anorectal manometry), typically to evaluate the rectosphincteric reflex upon balloon dilation. The device is typically used in the investigation of lower bowel disorders such as faecal incontinence or Hirschsprung's disease (HD). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNQ	Dilator, Esophageal
FGE	Catheter, Biliary, Diagnostic

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: 1c46cf5d-46d4-4f2a-86ec-c4c37502625e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: March 01, 2016