Peritoneal Dialysis Catheter Adapter

Basic Information

• Brand Name: Peritoneal Dialysis Catheter Adapter
• Primary DI: 00792079000394
• Version / Model: TA-200
• Catalog Number: TA-200
• Company Name: Medionics International Inc
• Labeler DUNS: 241421320
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-09
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 5c237518-6f15-48a8-8361-74630be6f692

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
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35944	Peritoneal dialysis catheter adaptor, single-use	A connecting device, often in two pieces, intended to be used to join a peritoneal dialysis catheter to the dialysate line during treatment. It is typically made of plastic or metal and may be used when the devices to be connected are from different manufacturers and not compatible, enabling them to mate, and/or within a mechanical connection system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00792079000394	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K993149	000