RediCath HS1216

GUDID 10851809002194

RediCath Hydrophilic Catheter

HR PHARMACEUTICALS INC.

Urine-sampling urethral catheter

• Primary Device ID: 10851809002194
• NIH Device Record Key: a1d63d85-7e0b-489f-9311-e60faab82c71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RediCath
• Version Model Number: HS1216
• Catalog Number: HS1216
• Company DUNS: 828918164
• Company Name: HR PHARMACEUTICALS 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: 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

Customer Support Contacts

• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851809002197 [Primary]
GS1	10851809002194 [Package]; Contains: 00851809002197; Package: Box [30 Units]; In Commercial Distribution
GS1	50851809002192 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142767

FDA Product Code

• GBM: CATHETER, URETHRAL

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: 2020-02-28
• Device Publish Date: 2020-02-20

On-Brand Devices [RediCath]

• 00851809002982: RediCath Hydrophilic Coude Catheter
• 00851809002975: RediCath Hydrophilic Coude Catheter
• 00851809002968: RediCath Hydrophilic Coude Catheter
• 50851809002994: RediCath Hydrophilic Coude Catheter
• 50851809002956: RediCath Hydrophilic Catheter
• 50851809002949: RediCath Hydrophilic Catheter
• 10851809002934: RediCath Hydrophilic Catheter
• 50851809002925: RediCath Hydrophilic Catheter
• 50851809002918: RediCath Hydrophilic Catheter
• 50851809002345: RediCath Hydrophilic Catheter
• 10851809002194: RediCath Hydrophilic Catheter
• 50851809002178: RediCath Hydrophilic Catheter
• 50851809002154: RediCath Hydrophilic Catheter
• 10851809002613: RediCath Hydrophilic Catheter