allFlex UC-AO3

GUDID 10819374024966

allFlex Ureteral Catheter Angle Open Tip 3F, 70cm

ALLWIN MEDICAL DEVICES, INC.

Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter

• Primary Device ID: 10819374024966
• NIH Device Record Key: f06377b7-380e-40ec-924d-488a3d8c6d7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: allFlex
• Version Model Number: allFlex Ureteral Catheter Angle Open Tip 3F, 70cm
• Catalog Number: UC-AO3
• Company DUNS: 796354509
• Company Name: ALLWIN MEDICAL DEVICES, INC.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819374024969 [Primary]
GS1	10819374024966 [Package]; Contains: 00819374024969; Package: Box Packing [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220730

FDA Product Code

• KOD: Catheter, Urological

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: 2023-08-09
• Device Publish Date: 2023-08-01

Devices Manufactured by ALLWIN MEDICAL DEVICES, INC.

• 00812261016597 - ASPI: 2024-02-16 ASPI Aspiration Needle 22G,30cm
• 10819374020401 - Krait: 2023-08-09 Krait Ureteral Catheter Open Tip 4F, 70cm
• 10819374020418 - Krait: 2023-08-09 Krait Ureteral Catheter Open Tip 3F, 70cm
• 10819374022382 - Krait: 2023-08-09 Krait Ureteral Catheter Closed Tip 3F, 70cm
• 10819374022399 - Krait: 2023-08-09 Krait Ureteral Catheter Closed Tip 4F, 70cm
• 10819374022405 - Krait: 2023-08-09 Krait Ureteral Catheter Closed Tip 5F, 70cm
• 10819374023174 - Krait: 2023-08-09 Krait Ureteral Catheter Closed Tip 6F, 70cm
• 10819374024379 - Krait: 2023-08-09 Krait Ureteral Catheter Open Tip 7F, 70cm