Certa Catheter

GUDID 05902194190374

Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of medication for regional anesthesia and pain management in

FERROSAN MEDICAL DEVICES SP Z O O

Anaesthesia conduction catheter Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated Peripheral anaesthesia catheter set, non-medicated

• Primary Device ID: 05902194190374
• NIH Device Record Key: caf811bf-5136-4d7f-b7ae-2e0ca23f1862
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Certa Catheter
• Version Model Number: R120C1
• Company DUNS: 426737794
• Company Name: FERROSAN MEDICAL DEVICES SP Z O O
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05902194190350 [Primary]
GS1	05902194190367 [Package]; Contains: 05902194190350; Package: Retail box [5 Units]; In Commercial Distribution
GS1	05902194190374 [Package]; Contains: 05902194190350; Package: Shipper box [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171193

FDA Product Code

• BSO: Catheter, Conduction, Anesthetic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-02-21

On-Brand Devices [Certa Catheter]

• 05902194190466: Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of me
• 05902194190435: Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of me
• 05902194190404: Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of me
• 05902194190374: Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of me
• 05902194190343: Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of me
• 05902194190312: Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of me