STAT 2

Basic Information

• Brand Name: STAT 2
• Primary DI: 30653405033046
• Version / Model: P-S2V-60
• Catalog Number: P-S2V-60
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 48
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2023-08-07
• Public Version Status: Update
• Public Device Record Key: 4438a05e-c6a1-48bd-ba72-c3ffdc18d8e9
• Distribution End Date: 2023-08-04

Device Description

Primary Administration Set Gravity Flow Controller

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58977	Basic intravenous administration set, noninvasive	A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20653405033049	GS1	BOX	48	Not in Commercial Distribution	2023-08-04
Primary	30653405033046	GS1
Unit of Use	00653405033045	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius