Jigsaw Medical, LLC

Basic Information

• Brand Name: Jigsaw Medical, LLC
• Primary DI: 00856274008002
• Version / Model: A21418
• Catalog Number: A21418
• Company Name: JIGSAW MEDICAL, LLC
• Labeler DUNS: 079233827
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-14
• Public Version: 1
• Public Version Date: 2019-08-22
• Public Version Status: New
• Public Device Record Key: 4665911c-600b-4c24-aa05-0c5ca62aab60

Device Description

Plastic adapter that allows for a luer lock drain line to connect to a press fit catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: 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
KGZ	Accessories, Catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46115	General-purpose catheter connector, sterile	A small sterile device intended to create a mechanical union between a catheter and an external device (non-dedicated) typically via a Luer connection; it has an intended use profile that is not dedicated to a specific type of catheter (i.e., can be applied to catheters specific to different anatomical sites and body fluids). It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856274008002	GS1
Package	00856274008033	GS1	Case	100	In Commercial Distribution