Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780431206
• Version / Model: CUS265-01
• Catalog Number: CUS265-01
• Company Name: INTEGRA PAIN MANAGEMENT
• Labeler DUNS: 030370299
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-20
• Public Version: 4
• Public Version Date: 2023-12-05
• Public Version Status: Update
• Public Device Record Key: 8bd785d4-6cbb-4698-bf59-fdecaf587971
• Distribution End Date: 2019-12-31

Device Description

Catheterization Tray

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61594	Central venous catheterization kit, short-term	A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	10381780263517	GS1
Package	30381780431200	GS1	Case	10	Not in Commercial Distribution	2019-12-31
Primary	10381780431206	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K960248	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Use if Package is Damaged
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit