Disposable IV Catheter

GUDID 36941512151062

Shinva Ande Healthcare Apparatus Co., Ltd

Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula

• Primary Device ID: 36941512151062
• NIH Device Record Key: aecacd12-8c2a-4adb-9b3d-bdc142e8ce3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable IV Catheter
• Version Model Number: IVC09-22
• Company DUNS: 421062164
• Company Name: Shinva Ande Healthcare Apparatus Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	16941512151068 [Primary]
GS1	36941512151062 [Package]; Contains: 16941512151068; Package: box [50 Units]; In Commercial Distribution
GS1	56941512151066 [Package]; Package: case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202060

FDA Product Code

• FOZ: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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: 2023-05-16
• Device Publish Date: 2023-05-08

On-Brand Devices [Disposable IV Catheter]

• 36941512151086: IVC09-26
• 36941512151079: IVC09-24
• 36941512151062: IVC09-22
• 36941512151055: IVC09-20
• 36941512151048: IVC09-18
• 36941512151031: IVC09-16
• 36941512151024: IVC09-14
• 36941512150942: IVC07-26
• 36941512150935: IVC07-24
• 36941512150928: IVC07-22
• 36941512150911: IVC07-20
• 36941512150904: IVC07-18
• 36941512150898: IVC07-16
• 36941512150881: IVC07-14