HTx Procedure Pack

GUDID 26974880991421

The procedure pack is an accessory kit of the HTx disposable hysteroscope system, which contains an inflow tubing, a drainage fluid tube and an under buttocks drape. The inflow tubing contains a luer connector and a non-vented spile, and is used to connect the inflow port of the HTx hysteroscope and the saline bag to provide the distension fluid inflow. The drainage fluid tube contains a luer connector, and is used to be connected to the outflow port of the hysteroscope for the discharge of fluid. The under buttocks drape is used to be placed under the patients’ buttocks and contains a fluid collection pouch to collect the discharged fluid.

Suzhou AcuVu medical technology Co., Ltd.

Suction/irrigation tubing, single-use

• Primary Device ID: 26974880991421
• NIH Device Record Key: 07457171-7665-4eea-9ee1-a7188d90b4c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HTx Procedure Pack
• Version Model Number: inflow tubing+ drainage fluid tube + under buttoc
• Company DUNS: 705464292
• Company Name: Suzhou AcuVu medical technology 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com
• Phone: 6178344997
• Email: frank.huang@sz-acuvu.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974880991427 [Primary]
GS1	26974880991421 [Package]; Contains: 06974880991427; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• NWW: Hysteroscope Accessories

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: 2024-07-08
• Device Publish Date: 2024-06-28

Devices Manufactured by Suzhou AcuVu medical technology Co., Ltd.

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• 26974880991452 - HTx Disposable Hysteroscope: 2025-05-16 Disposable hysteroscope with a working channel suitable for 9Fr tools to cut and remove uterine lesions. The outer diameter of t
• 06974880991632 - HTx Disposable Hysteroscope: 2025-05-16 Disposable hysteroscope with a working channel suitable for 9Fr tools to cut and remove uterine lesions. The outer diameter of t
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• 16974880993138 - Biopsy forceps: 2025-05-16 The biopsy forceps are intended for use in hysteroscopy procedure to obtain tissue samples for examination of tissue from the u
• 16974880993145 - Serrated forceps: 2025-05-16 The serrated forceps are intended for use in hysteroscopy procedure to obtain tissue samples for examination of tissue from the
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• 16974880993169 - Hook grasper: 2025-05-16 The hook grasper is intended to be used in hysteroscopy procedure for retrieval of foreign bodies and tissues from the uterine