Genotropin Pen® 5

Basic Information

• Brand Name: Genotropin Pen® 5
• Primary DI: 10300134761929
• Version / Model: F000116153
• Company Name: PHARMACIA & UPJOHN COMPANY LLC
• Labeler DUNS: 618054084
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-05
• Public Version: 3
• Public Version Date: 2020-12-18
• Public Version Status: Update
• Public Device Record Key: 3d8005b0-4ead-4749-907d-b43921198ae2

Device Description

A non-sterile, reusable pen injector designed to be used by a patient to subcutaneously inject human growth hormone using a replaceable Two-Chamber Cartridge (TCC) containing Genotropin growth hormone inserted into the device.

Device Characteristics

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSC	Injector, Pen	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45771	Cartridge-accepting autoinjector, mechanical	A portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and typically a dial on the device is operated for dosing (e.g., via a spring-loaded mechanism); the cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10300134761929	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius