PITON™ TRI-ADAPTOR

Basic Information

• Brand Name: PITON™ TRI-ADAPTOR
• Primary DI: 70681490225747
• Version / Model: AC4002M
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-02
• Public Version: 5
• Public Version Date: 2022-09-22
• Public Version Status: Update
• Public Device Record Key: 4f3dbf8e-de79-4fca-9d62-23066b1ba354
• Distribution End Date: 2019-10-21

Device Description

ADAPTER AC4002M TRI W/METAL GDWR 5PK

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTL	Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass	Cardiovascular	870.4290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60538	Luer/Luer linear connector, single-use	A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00681490225748	GS1	PK	5	Not in Commercial Distribution	2019-10-21
Primary	70681490225747	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K940063	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store accessories in a clean, cool and dark area.