NAJA 9A-03110

GUDID 00191506060985

Gastrointestinal Balloon Catheter

Médical Chess Inc

Enteroclysis balloon catheter

• Primary Device ID: 00191506060985
• NIH Device Record Key: a160d5bc-103f-4b4e-83e7-90ff33fa6cdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAJA
• Version Model Number: 9A-03110
• Catalog Number: 9A-03110
• Company DUNS: 243279393
• Company Name: Médical Chess Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506060985 [Primary]

FDA Product Code

• FGD: CATHETER, RETENTION, BARIUM ENEMA WITH BAG

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-02
• Device Publish Date: 2025-05-23