SafeTPoint SBCSBWH2503412

GUDID 16971564465998

The Safety blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients, and the safety sheath is designed to aid in the reduction of accidental needlesticks.

Jiangsu Caina Medical Co.,Ltd

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• Primary Device ID: 16971564465998
• NIH Device Record Key: afbe8836-333b-480f-a302-b709c6f728ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeTPoint
• Version Model Number: 25G*3/4"*12"
• Catalog Number: SBCSBWH2503412
• Company DUNS: 544543513
• Company Name: Jiangsu Caina Medical 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 25 Gauge
• Length: 0.75 Inch
• Length: 12 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971564465991 [Primary]
GS1	16971564465998 [Package]; Contains: 06971564465991; Package: [25 Units]; In Commercial Distribution
GS1	26971564465995 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151991

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2022-09-12
• Device Publish Date: 2022-09-02

On-Brand Devices [SafeTPoint]

• 16971564466018: The Safety blood collection sets are intended to be used with vacuum blood collection tube for v
• 16971564466001: The Safety blood collection sets are intended to be used with vacuum blood collection tube for v
• 16971564465998: The Safety blood collection sets are intended to be used with vacuum blood collection tube for v
• 16971564465912: The Safety blood collection sets are intended to be used with vacuum blood collection tube for v