Nexpowder

GUDID 18800038405186

Nexpowder is used for hemostasis of non-variceal, upper gastrointestinal bleeding.

NEXTBIOMEDICAL CO., LTD.

Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent

• Primary Device ID: 18800038405186
• NIH Device Record Key: 82d579d2-db9c-4f3e-9b1b-278c8c9f7fe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexpowder
• Version Model Number: NHS03
• Company DUNS: 689845781
• Company Name: NEXTBIOMEDICAL CO., LTD.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800038405189 [Primary]
GS1	18800038405186 [Package]; Contains: 08800038405189; Package: box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202929

FDA Product Code

• QAU: Hemostatic Device For Endoscopic Gastrointestinal Use

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: 2022-10-05
• Device Publish Date: 2022-09-27

On-Brand Devices [Nexpowder]

• 18800038405186: Nexpowder is used for hemostasis of non-variceal, upper gastrointestinal bleeding.
• 08800038405332: Nexpowder is used for hemostasis of non-variceal, upper gastrointestinal bleeding.
• 08800038405325: expowder is used for hemostasis of non-variceal, upper gastrointestinal bleeding.