AccessGUDID - DEVICE: BOEHRINGER® Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System (10816286020659)

GUDID

Device Identifier (DI) Information

Brand Name: BOEHRINGER® Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System
Version or Model: 5250
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOEHRINGER LABORATORIES, LLC

Primary DI Number: 10816286020659
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079991657 *Terms of Use

Device Description: Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System

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?
37883	General positive-pressure manual hand inflator	A hand-operated manual device designed to draw in ambient air and expel the air from a connected nozzle to inflate a device (e.g., mattress, patient head support rings); it is not intended to be used with invasive devices. It is typically designed as a bicycle pump, a stirrup pump, or a large syringe-like pump, and is designed for use in the home and healthcare facilities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	Tubes, Gastrointestinal (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130483	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 37726d97-c993-4ee4-9997-be51d1cd58e0
Public Version Date: September 19, 2024
Public Version Number: 5
DI Record Publish Date: August 01, 2016