Insufflation tube

GUDID 06973031299870

Guangdong Optomedic Technologies, Inc.

Endoscopic insufflation tubing set, reusable

• Primary Device ID: 06973031299870
• NIH Device Record Key: 95a29697-d6d5-434a-8546-bbcba37ceb87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insufflation tube
• Version Model Number: OPTO-T1000H
• Company DUNS: 544527790
• Company Name: Guangdong Optomedic Technologies, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	06973031299870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231342

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

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

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

[06973031299870]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-03
• Device Publish Date: 2024-03-26

On-Brand Devices [Insufflation tube]

• 06973031299870: OPTO-T1000H
• 06973031299573: OPTO-T1000