PVC Hydrophilic Urethral Catheter

GUDID 86971976782385

Bending head normal type,Catheter OD.16Fr

Chengdu Daxan Innovative Medical Tech. Co., Ltd.

Intermittent urethral drainage catheter, non-antimicrobial, single-use

• Primary Device ID: 86971976782385
• NIH Device Record Key: deb24923-06b9-4263-aa1b-6f65bd67f3a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PVC Hydrophilic Urethral Catheter
• Version Model Number: H01-16W
• Company DUNS: 554453716
• Company Name: Chengdu Daxan Innovative Medical Tech. Co., Ltd.
• Device Count: 30
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971976782389 [Primary]
GS1	86971976782385 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212567

FDA Product Code

• EZD: Catheter, Straight

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: 2023-10-03
• Device Publish Date: 2023-09-25

On-Brand Devices [PVC Hydrophilic Urethral Catheter]

• 86971976787465: Woman water sachet type,Catheter OD.16Fr
• 86971976787618: Bending head water sachet type,Catheter OD.16Fr
• 86971976787571: Bending head water sachet type,Catheter OD.14Fr
• 86971976787564: Bending head water sachet type,Catheter OD.12Fr
• 86971976787540: Bending head water sachet type,Catheter OD.10Fr
• 86971976787519: Woman water sachet type,Catheter OD.18Fr
• 86971976787427: Woman water sachet type,Catheter OD.14Fr
• 86971976787410: Woman water sachet type,Catheter OD.12Fr
• 86971976787397: Woman water sachet type,Catheter OD.10Fr
• 86971976787366: Woman water sachet type,Catheter OD.8Fr
• 86971976787359: Man water sachet type,Catheter OD.18Fr
• 86971976787298: Man water sachet type,Catheter OD.16Fr
• 86971976787267: Man water sachet type,Catheter OD.14Fr
• 86971976787205: Man water sachet type,Catheter OD.12Fr
• 86971976786994: Bending head normal type,Catheter OD.14Fr
• 86971976786987: Bending head normal type,Catheter OD.12Fr
• 86971976786918: Bending head normal type,Catheter OD.10Fr
• 86971976786901: Woman normal type,Catheter OD.18Fr
• 06971976782419: Man water sachet type, Catheter OD.10Fr
• 86971976782385: Bending head normal type,Catheter OD.16Fr
• 86971976782330: Man water sachet type,Catheter OD.8Fr
• 86971976786871: Woman normal type,Catheter OD.16Fr
• 86971976786864: Woman normal type,Catheter OD.14Fr
• 86971976786857: Woman normal type,Catheter OD.12Fr
• 86971976786819: Woman normal type,Catheter OD.10Fr
• 86971976786796: Woman normal type,Catheter OD.8Fr
• 86971976786789: Man normal type,Catheter OD.18Fr
• 86971976786758: Man normal type,Catheter OD.16Fr
• 86971976786727: Man normal type,Catheter OD.14Fr
• 86971976786680: Man normal type,Catheter OD.12Fr
• 86971976786666: Man normal type. Catheter OD. Φ 10Fr
• 86971976786635: Man normal type,Catheter OD.8Fr