Orbit®Inserter

Basic Information

• Brand Name: Orbit®Inserter
• Primary DI: 07613117021979
• Version / Model: 700012060
• Catalog Number: 700012060
• Company Name: Ypsomed AG
• Labeler DUNS: 481742760
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0369d3aa-764a-4d6c-809f-129490aa0059

Device Description

Insertion Device for Ypsomed Infusion Sets

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KZH	INTRODUCER, SYRINGE NEEDLE	General Hospital	880.6920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60415	Insulin infusion cannula introducer	A non-sterile, hand-held, mechanical device intended to aid introduction of a cannula/needle subcutaneously into fatty tissue for use with an insulin infusion pump. It typically consists of a small housing that chambers the cannula and a triggered release mechanism for automated insertion of the cannula/needle into tissues. It is intended for use in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07613117022235	GS1	SHIPPER BOX	10	In Commercial Distribution
Primary	07613117021979	GS1

Customer Contacts

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