IMPROVACUTER® Blood Collection Set

GUDID 46933395620060

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: 46933395620060
• NIH Device Record Key: c565d826-12dc-4367-9558-e32f5be82277
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPROVACUTER® Blood Collection Set
• Version Model Number: 25G x 3/4” 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	06933395620062 [Primary]
GS1	16933395620069 [Package]; Contains: 06933395620062; Package: [100 Units]; In Commercial Distribution
GS1	46933395620060 [Package]; Contains: 16933395620069; 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 [IMPROVACUTER® Blood Collection Set]

• 56933395620234: 27G x 2/5” x 7”
• 56933395620227: 25G x 3/4” x 7”
• 56933395620210: 23G x 3/4” x 7”
• 56933395620203: 21G x 3/4” x 7”
• 56933395620197: 27G x 2/5” x 12”
• 56933395620180: 25G x 3/4” x 12”
• 56933395620173: 23G x 3/4” x 12”
• 56933395620166: 21G x 3/4” x 12”
• 46933395620152: 27G x 2/5” x 7”
• 46933395620145: 25G x 3/4” x 7”
• 46933395620138: 23G x 3/4” x 7”
• 46933395620121: 21G x 3/4” x 7”
• 46933395620114: 27G x 2/5” x 12”
• 46933395620107: 25G x 3/4” x 12”
• 46933395620091: 23G x 3/4” x 12”
• 46933395620084: 21G x 3/4” x 12”
• 46933395620077: 27G x 2/5” x 7”
• 46933395620060: 25G x 3/4” x 7”
• 46933395620053: 23G x 3/4” x 7”
• 46933395620046: 21G x 3/4” x 7”
• 46933395620039: 27G x 2/5” x 12”
• 46933395620022: 25G x 3/4” x 12”
• 46933395620015: 23G x 3/4” x 12”
• 46933395620008: 21G x 3/4” x 12”