IMPROVACUTER® Multi Sample Needle

GUDID 46933395621210

Guangzhou Improve Medical Instruments Co., Ltd.

Blood collection needle

• Primary Device ID: 46933395621210
• NIH Device Record Key: 894df044-8730-49b1-8886-1e39c6482940
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPROVACUTER® Multi Sample Needle
• Version Model Number: 21G × 1 1/2″
• Company DUNS: 530148444
• Company Name: Guangzhou Improve Medical Instruments Co., Ltd.
• Device Count: 100
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06933395621212 [Unit of Use]
GS1	16933395621219 [Primary]
GS1	46933395621210 [Package]; Contains: 16933395621219; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153388

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-08
• Device Publish Date: 2016-12-26

On-Brand Devices [IMPROVACUTER® Multi Sample Needle]

• 46933395621234: 22G × 1 1/2″
• 46933395621227: 22G × 1″
• 46933395621210: 21G × 1 1/2″
• 46933395621203: 21G × 1″