IMPROSAFE® Blood Collection Set

GUDID 16974481830962

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: 16974481830962
• NIH Device Record Key: 16a41f0a-d495-4bcb-9fe5-d221685df679
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPROSAFE® Blood Collection Set
• Version Model Number: 25G x 3/4” x 12”
• 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	06974481830965 [Primary]
GS1	16974481830962 [Package]; Contains: 06974481830965; Package: [50 Units]; In Commercial Distribution
GS1	26974481830969 [Package]; Contains: 06974481830965; Package: [100 Units]; In Commercial Distribution
GS1	46974481830963 [Package]; Package: [20 Units]; In Commercial Distribution
GS1	56974481830960 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	66974481830967 [Package]; Package: [4 Units]; In Commercial Distribution
GS1	76974481830964 [Package]; Package: [12 Units]; In Commercial Distribution
GS1	86974481830961 [Package]; Contains: 26974481830969; Package: [20 Units]; In Commercial Distribution
GS1	96974481830968 [Package]; Contains: 66974481830967; 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: 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]

• 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”