insuflon

Basic Information

• Brand Name: insuflon
• Primary DI: 05705244016590
• Version / Model: 98-000-2612
• Company Name: Unomedical A/S
• Labeler DUNS: 306032491
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-01-09
• Public Version: 4
• Public Version Date: 2021-01-08
• Public Version Status: Update
• Public Device Record Key: 57279a98-c517-4185-9081-44fee9e0c7b7

Device Description

Single use indwelling catheter for multiple subcutaneous injections. The indwelling catheter must be used as described in the Instructions for Use.

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: 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
FOZ	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17180	Subcutaneous infusion/injection port needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05705244016606	GS1	Outer Box	200	In Commercial Distribution
Primary	05705244016590	GS1
Unit of Use	05705244016613	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	27	Gauge
Angle	30	degree

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect from direct sunlight and store at room temperature