IMPROSAFE® Blood Collection Set

GUDID 46933395620398

Guangzhou Improve Medical Instruments Co., Ltd.

Blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle Non-fixed blood collection needle

• Primary Device ID: 46933395620398
• NIH Device Record Key: a4814e21-373a-430f-bb2a-fd7bf431d931
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPROSAFE® Blood Collection Set
• Version Model Number: 27G x 2/5” x 7”
• 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	06933395620390 [Primary]
GS1	16933395620397 [Package]; Contains: 06933395620390; Package: [100 Units]; In Commercial Distribution
GS1	46933395620398 [Package]; Contains: 16933395620397; Package: [20 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® Blood Collection Set]

• 76933395620474: 27G x 2/5” x 7”
• 76933395620467: 25G x 3/4” x 7”
• 76933395620450: 23G x 3/4” x 7”
• 76933395620443: 21G x 3/4” x 7”
• 76933395620436: 27G x 2/5” x 12”
• 76933395620429: 25G x 3/4” x 12”
• 76933395620412: 23G x 3/4” x 12”
• 76933395620405: 21G x 3/4” x 12”
• 46933395620398: 27G x 2/5” x 7”
• 46933395620381: 25G x 3/4” x 7”
• 46933395620374: 23G x 3/4” x 7”
• 46933395620367: 21G x 3/4” x 7”
• 46933395620350: 27G x 2/5” x 12”
• 46933395620343: 25G x 3/4” x 12”
• 46933395620336: 23G x 3/4” x 12”
• 46933395620329: 21G x 3/4” x 12”
• 46933395620312: 27G x 2/5” x 7”
• 46933395620305: 25G x 3/4” x 7”
• 46933395620299: 23G x 3/4” x 7”
• 46933395620282: 21G x 3/4” x 7”
• 46933395620275: 27G x 2/5” x 12”
• 46933395620268: 25G x 3/4” x 12”
• 46933395620251: 23G x 3/4” x 12”
• 46933395620244: 21G x 3/4” x 12”
• 16974481831006: 25G x 3/4” x 7”
• 16974481830993: 23G x 3/4” x 7”
• 16974481830962: 25G x 3/4” x 12”
• 06974481830958: 23G x 3/4” x 12”