SKATER™ All Purpose and Nephrostomy Drainage Set

Basic Information

• Brand Name: SKATER™ All Purpose and Nephrostomy Drainage Set
• Primary DI: 00886333225071
• Version / Model: 756606025
• Catalog Number: 756606025
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-13
• Public Version: 1
• Public Version Date: 2022-07-21
• Public Version Status: New
• Public Device Record Key: af87d395-a594-454c-a95b-7581c3c77834

Device Description

SKATER™ All Purpose and Nephrostomy Drainage Set Locking 6F x 25cm

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47796	Multi-purpose percutaneous abdominothoracic drainage catheter	A flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. Disposable devices dedicated to catheter introduction may be included with the device. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886333225075	GS1	Box	5	In Commercial Distribution
Primary	00886333225071	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6F x 25cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and away from sunlight