AccessGUDID - DEVICE: FUJIFILM (04547410331370)

GUDID

Device Identifier (DI) Information

Brand Name: FUJIFILM
Version or Model: BS-2
Catalog Number:
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410331370
Issuing Agency: GS1
Device Count: 10

Device Description: The balloon is intended to be used in combination with Double Balloon Endoscopes to assist with insertion inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Gastrointestinal dilation balloon catheter	A long, thin, flexible tube with an inflatable balloon at its distal tip typically used to endoscopically dilate gastrointestinal strictures, especially of the oesophagus, pylorus, and colon. The balloon is inflated to its prescribed diameter (typically between 6 mm and 20 mm) to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Gastrointestinal dilation balloon catheter

A long, thin, flexible tube with an inflatable balloon at its distal tip typically used to endoscopically dilate gastrointestinal strictures, especially of the oesophagus, pylorus, and colon. The balloon is inflated to its prescribed diameter (typically between 6 mm and 20 mm) to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
FDA	Enteroscope and accessories

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
High-level Disinfectant

Storage and Handling

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Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify: There must be no condensation.
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Temperature: between 10 and 40 Degrees Celsius