CAINA BC032375

GUDID 16971564466049

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

Blood collection set, invasive

• Primary Device ID: 16971564466049
• NIH Device Record Key: 8d5c7144-12a2-47cc-b968-d77e6ea96ac8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAINA
• Version Model Number: 23G*3/4"*12"
• Catalog Number: BC032375
• 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: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch
• Needle Gauge: 23 Gauge
• Length: 0.75 Inch
• Length: 12 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971564466042 [Primary]
GS1	16971564466049 [Package]; Contains: 06971564466042; Package: [50 Units]; In Commercial Distribution
GS1	26971564466046 [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 [CAINA]

• 16971564465158: Syringe with safety needle 3ml 25Gx1.The Syringe with Safety Needle is intended for use in the a
• 16971564465202: Syringe with safety needle 1ml 23Gx1".The Syringe with Safety Needle is intended for use in the
• 16971564465196: Syringe with safety needle 3ml 25Gx1.5".The Syringe with Safety Needle is intended for use in th
• 16971564465189: Syringe with safety needle 3ml 23Gx1.5".The Syringe with Safety Needle is intended for use in th
• 16971564465172: Syringe with safety needle 3ml 23Gx1".The Syringe with Safety Needle is intended for use in the
• 16971564465165: 1 ml luer lock disposable syringe without needle.The syringes are intended to inject fluids into
• 16971564465264: 1 ml luer lock disposable syringe without needle.The syringes are intended to inject fluids into
• 16971564465257: Safety needle 25Gx1.5".The Safety Needle is intended for use with a luer lock syringe for aspira
• 16971564465240: Safety needle 25Gx1".The Safety Needle is intended for use with a luer lock syringe for aspirati
• 16971564465233: Safety needle 23Gx1.5”.The Safety Needle is intended for use with a luer lock syringe for aspi
• 16971564465226: Safety needle 23Gx1.The Safety Needle is intended for use with a luer lock syringe for aspiratio
• 16971564465219: 3 ml luer lock disposable syringe without needle.The syringes are intended to inject fluids into
• 16971564465288: 1ml luer silp Syringe with needle 25Gx1".Syringes with needle are intended to inject fluids into
• 16971564465271: Disposable Needle 23Gx1”.Needles are intended to be used with a legally marketed syringe inten
• 16971564465387: 1 ml luer lock syringe with needle 25Gx1.The syringes are intended to inject fluids into or with
• 16971564465370: Safety needle 21Gx1.5".The Safety Needle is intended for use with a luer lock syringe for aspira
• 16971564465318: 3 ml luer lock syringe with needle 25Gx1.The syringes are intended to inject fluids into or with
• 16971564465301: 3ml luer lock syringe with needle 23GX1.The syringes are intended to inject fluids into or withd
• 16971564465295: 1 ml luer silp Syringe with needle 23Gx1".Syringes with needle are intended to inject fluids in
• 16971564465486: Syringe with safety needle 1ml 25Gx1".The Syringe with Safety Needle is intended for use in the
• 16971564465615: The Syringe with permanently attached needle is intended for use by health care professionals fo
• 16971564465493: Syringe with safety needle 1ml 25Gx5/8".The Syringe with Safety Needle is intended for use in th
• 16971564465332: Safety needle 25Gx5/8".The Safety Needle is intended for use with a luer lock syringe for aspira
• 16971564465936: The Safelock disposable blood collection sets are intended to be used with vacuum blood collecti
• 16971564465929: The Safelock disposable blood collection sets are intended to be used with vacuum blood collecti
• 16971564465875: The syringes are intended to inject fluids into or withdraw fluids from the body.
• 16971564466049: The Safety blood collection sets are intended to be used with vacuum blood collection tube for v
• 16971564466032: The Safety blood collection sets are intended to be used with vacuum blood collection tube for v
• 16971564466025: The Syringe with permanently attached needle is intended for use by health care professionals fo