IMPROSAFE® Blood Collection Set with Pre-Attached

GUDID 66933395620576

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: 66933395620576
• NIH Device Record Key: d8bea0f0-8f5e-42da-9f80-2f3faebb9d90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPROSAFE® Blood Collection Set with Pre-Attached
• Version Model Number: 23G x 3/4” x 12”
• 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	06933395620574 [Primary]
GS1	16933395620571 [Package]; Contains: 06933395620574; Package: [50 Units]; In Commercial Distribution
GS1	26933395620578 [Package]; Contains: 06933395620574; Package: [25 Units]; In Commercial Distribution
GS1	46933395620572 [Package]; Contains: 16933395620571; Package: [10 Units]; In Commercial Distribution
GS1	56933395620579 [Package]; Contains: 16933395620571; Package: [4 Units]; In Commercial Distribution
GS1	66933395620576 [Package]; Contains: 26933395620578; 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® Blood Collection Set with Pre-Attached ]

• 66933395620712: 27G x 2/5” x 7”
• 66933395620705: 25G x 3/4” x 7”
• 66933395620699: 23G x 3/4” x 7”
• 66933395620682: 21G x 3/4” x 7”
• 66933395620675: 27G x 2/5” x 12”
• 66933395620668: 25G x 3/4” x 12”
• 66933395620651: 23G x 3/4” x 12”
• 66933395620644: 21G x 3/4” x 12”
• 66933395620637: 27G x 2/5” x 7”
• 66933395620620: 25G x 3/4” x 7”
• 66933395620613: 23G x 3/4” x 7”
• 66933395620606: 21G x 3/4” x 7”
• 66933395620590: 27G x 2/5” x 12”
• 66933395620583: 25G x 3/4” x 12”
• 66933395620576: 23G x 3/4” x 12”
• 66933395620569: 21G x 3/4” x 12”
• 66933395620552: 27G x 2/5” x 7”
• 66933395620545: 25G x 3/4” x 7”
• 66933395620538: 23G x 3/4” x 7”
• 66933395620521: 21G x 3/4” x 7”
• 66933395620514: 27G x 2/5” x 12”
• 66933395620507: 25G x 3/4” x 12”
• 66933395620491: 23G x 3/4” x 12”
• 66933395620484: 21G x 3/4” x 12”