IMPROVACUTER® Blood Collection Set with Pre-Attac

GUDID 56933395621125

Guangzhou Improve Medical Instruments Co., Ltd.

Blood collection needle

• Primary Device ID: 56933395621125
• NIH Device Record Key: d5c8fa66-1328-4966-9946-afdb5ef54ea4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPROVACUTER® Blood Collection Set with Pre-Attac
• Version Model Number: 21G 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	06933395621120 [Primary]
GS1	16933395621127 [Package]; Contains: 06933395621120; Package: [50 Units]; In Commercial Distribution
GS1	46933395621128 [Package]; Contains: 16933395621127; Package: [10 Units]; In Commercial Distribution
GS1	56933395621125 [Package]; Contains: 16933395621127; Package: [4 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 with Pre-Attac]

• 56933395621194: 27G x 2/5” x 7”
• 56933395621187: 25G x 3/4” x 7”
• 56933395621170: 23G x 3/4” x 7”
• 56933395621163: 21G x 3/4” x 7”
• 56933395621156: 27G x 2/5” x 12”
• 56933395621149: 25G x 3/4” x 12”
• 56933395621132: 23G x 3/4” x 12”
• 56933395621125: 21G x 3/4” x 12”
• 56933395621118: 27G x 2/5” x 7”
• 56933395621101: 25G x 3/4” x 7”
• 56933395621095: 23G x 3/4” x 7”
• 56933395621088: 21G x 3/4” x 7”
• 56933395621071: 27G x 2/5” x 12”
• 56933395621064: 25G x 3/4” x 12”
• 56933395621057: 23G x 3/4” x 12”
• 56933395621040: 21G x 3/4” x 12”
• 56933395621033: 27G x 2/5” x 7”
• 56933395621026: 25G x 3/4” x 7”
• 56933395621019: 23G x 3/4” x 7”
• 56933395621002: 21G x 3/4” x 7”
• 56933395620999: 27G x 2/5” x 12”
• 56933395620982: 25G x 3/4” x 12”
• 56933395620975: 23G x 3/4” x 12”
• 56933395620968: 21G x 3/4” x 12”