Certa Catheter

Basic Information

• Brand Name: Certa Catheter
• Primary DI: 05902194190299
• Version / Model: R50C1
• Company Name: FERROSAN MEDICAL DEVICES SP Z O O
• Labeler DUNS: 426737794
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-21
• Public Version: 7
• Public Version Date: 2020-07-22
• Public Version Status: Update
• Public Device Record Key: 30918ef0-265d-45e8-ad27-733080462063
• Distribution End Date: 2019-10-31

Device Description

Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of medication for regional anesthesia and pain management in lower extremity blocks. It may be used by a qualified healthcare professional in a perioperative monitored care setting. Certa Catheter™ is intended for use in adult patients only. It should always be inserted and placed under ultrasound guidance by a healthcare professional. The Certa Catheter has not been evaluated for use in upper extremity blocks.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46383	Peripheral anaesthesia catheter set, non-medicated	A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05902194190312	GS1	Shipper box	60	Not in Commercial Distribution	2019-10-31
Primary	05902194190299	GS1
Package	05902194190305	GS1	Retail box	5	Not in Commercial Distribution	2019-10-31

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity