IMPROSAFE® Blood Collection Set with Pre-Attached Holder

GUDID 16974481831075

Guangzhou Improve Medical Instruments Co., Ltd.

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

• Primary Device ID: 16974481831075
• NIH Device Record Key: 5ce7fbaf-7c0b-4f6f-812e-dee099e94f42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPROSAFE® Blood Collection Set with Pre-Attached Holder
• Version Model Number: 23G x 3/4” x 7”
• Company DUNS: 554555378
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974481831078 [Primary]
GS1	16974481831075 [Package]; Contains: 06974481831078; Package: [50 Units]; In Commercial Distribution
GS1	26974481831072 [Package]; Contains: 06974481831078; Package: [25 Units]; In Commercial Distribution
GS1	46974481831076 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	56974481831073 [Package]; Package: [4 Units]; In Commercial Distribution
GS1	76974481831077 [Package]; Contains: 26974481831072; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-28
• Device Publish Date: 2022-02-20

On-Brand Devices [IMPROSAFE® Blood Collection Set with Pre-Attached Holder]

• 16974481831075: 23G x 3/4” x 7”
• 16974481831037: 23G x 3/4” x 12”