AccessGUDID - DEVICE: Lumiflex (00724995244583)

GUDID

Device Identifier (DI) Information

Brand Name: Lumiflex
Version or Model: 00715515W
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00715515W
Company Name: US Endoscopy

Primary DI Number: 00724995244583
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/15mm wire is made of nylon and is a progressive stage balloon capable of three disctinct and progressively larger diameters via controlled radial expansion.

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:	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?
45712	Gastrointestinal/biliary dilation balloon catheter, non-medicated	A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNQ	Dilator, esophageal
FGE	Stents, drains and dilators for the biliary ducts

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241888	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
Special Storage Condition, Specify: Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials.

Clinically Relevant Size

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Size Type Text
Balloon Length: 5.5 Centimeter
Catheter Length: 240 Centimeter
Guidewire Diameter: 0.89 Millimeter

Device Record Status

Public Device Record Key: e0882c08-d1a1-4014-9bf4-fcc821452369
Public Version Date: June 11, 2025
Public Version Number: 1
DI Record Publish Date: June 03, 2025