IMPROSAFE® Blood Collection Set with Pre-Attached Holder

GUDID 16974481831037

Guangzhou Improve Medical Instruments Co., Ltd.

Non-fixed blood collection needle

• Primary Device ID: 16974481831037
• NIH Device Record Key: 29f5646f-8c13-46de-a340-1d574030ba21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPROSAFE® Blood Collection Set with Pre-Attached Holder
• Version Model Number: 23G 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	06974481831030 [Primary]
GS1	16974481831037 [Package]; Contains: 06974481831030; Package: [50 Units]; In Commercial Distribution
GS1	26974481831034 [Package]; Contains: 06974481831030; Package: [25 Units]; In Commercial Distribution
GS1	46974481831038 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	56974481831035 [Package]; Package: [4 Units]; In Commercial Distribution
GS1	76974481831039 [Package]; Contains: 26974481831034; 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”
• 06974481831023: 21G×3/4”×12”
• 26974481831058: 27G×2/5”×12”
• 26974481831041: 25G×3/4”×12”