IMPROSAFE® Multi Sample Needle

GUDID 56933395620814

Guangzhou Improve Medical Instruments Co., Ltd.

Blood collection needle

• Primary Device ID: 56933395620814
• NIH Device Record Key: 57864c5f-7d47-4c27-b977-7ea78f3da8e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPROSAFE® Multi Sample Needle
• Version Model Number: 21G × 1 1/2″
• Company DUNS: 530148444
• Company Name: Guangzhou Improve Medical Instruments 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: 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	06933395620819 [Primary]
GS1	16933395620816 [Package]; Contains: 06933395620819; Package: [50 Units]; In Commercial Distribution
GS1	26933395620813 [Package]; Contains: 06933395620819; Package: [25 Units]; In Commercial Distribution
GS1	46933395620817 [Package]; Contains: 16933395620816; Package: [10 Units]; In Commercial Distribution
GS1	56933395620814 [Package]; Contains: 16933395620816; Package: [4 Units]; In Commercial Distribution
GS1	66933395620811 [Package]; Contains: 26933395620813; Package: [8 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: 2016-12-23

On-Brand Devices [IMPROSAFE® Multi Sample Needle]

• 56933395620838: 22G × 1 1/2″
• 56933395620821: 22G × 1″
• 56933395620814: 21G × 1 1/2″
• 56933395620807: 21G × 1″
• 56933395620791: 22G × 1 1/2″
• 56933395620784: 22G × 1″
• 56933395620777: 21G × 1 1/2″
• 56933395620760: 21G × 1″
• 56933395620753: 22G × 1 1/2″
• 56933395620746: 22G × 1″
• 56933395620739: 21G × 1 1/2″
• 56933395620722: 21G × 1″