EMPAVELI® Injector

Basic Information

• Brand Name: EMPAVELI® Injector
• Primary DI: 00851869007019
• Version / Model: 30129903
• Catalog Number: 30129903
• Company Name: Enable Injections, Inc.
• Labeler DUNS: 961665911
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-30
• Public Version: 1
• Public Version Date: 2023-11-07
• Public Version Status: New
• Public Device Record Key: 6ffe7ef3-b52e-4815-8e09-414db3767084

Device Description

Single-use, disposable on body injector

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: 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: 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
QLF	On-Body Injector	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46542	Elastomeric infusion pump system	An assembly of devices that provides continuous and/or intermittent percutaneous infusion of a prescribed medicated solution to a patient through forces from elastic material. It typically consists of an elastomeric chamber (various sizes predetermine the flow and volume) that is filled with the solution using a dedicated filling device and/or syringe to create a pressure, tubing, particulate/air-eliminating filter, a flow restrictor, and a connector at the distal end for connection to the patient's access device. It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10851869007016	GS1	Case	8	In Commercial Distribution
Primary	00851869007019	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 41 – 104 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius