The O R Company - InsufflatOR Tubing Set

GUDID 04711605992053

ADVANCED MEDICAL DESIGN CO., LTD.

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 04711605992053
• NIH Device Record Key: 33a8984a-09b3-442c-a097-09101d4d4715
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The O R Company - InsufflatOR Tubing Set
• Version Model Number: PFITF-10
• Company DUNS: 656305567
• Company Name: ADVANCED MEDICAL DESIGN CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	04711605992053 [Primary]
GS1	04711605992060 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	04711605992077 [Package]; Contains: 04711605992060; Package: [60 Units]; In Commercial Distribution

FDA Product Code

• NKC: Tubing/Tubing With Filter, Insufflation, Laparoscopic

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: 2025-08-05
• Device Publish Date: 2025-07-28

Devices Manufactured by ADVANCED MEDICAL DESIGN CO., LTD.

• 04711605992053 - The O R Company - InsufflatOR Tubing Set: 2025-08-05
• 04711605992053 - The O R Company - InsufflatOR Tubing Set: 2025-08-05
• 04711605991667 - The OR Company-InsufflatOR Needle: 2018-03-29 Insufflation needle 12cm
• 04711605991674 - The OR Company-InsufflatOR Needle: 2018-03-29 Insufflation needle 15cm