Genotropin Mixer®

Basic Information

• Brand Name: Genotropin Mixer®
• Primary DI: 10300130923796
• Version / Model: F000092379
• Company Name: PFIZER INC.
• Labeler DUNS: 829076566
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 529a174f-25fa-4e9e-a112-00bfb67b0c14

Device Description

The Genotropin Mixer is a device used to mix growth hormone that is provided in a Two-Chamber Cartridge (TCC). The Genotropin Mixer is a non-sterile, reusable medical device designed for mixing the Genotropin TCC.

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: Yes
• 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
FMF	Syringe, piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46091	Basic growth hormone autoinjector, replaceable-cartridge	A portable hand-held device, typically in the form of a large pen, designed to be used by an adult or a child patient to subcutaneously inject a dose of human growth hormone through a replaceable needle. A replaceable cartridge filled with growth hormone medication is inserted into the device and typically a dial on the device is operated for dosing; only the cartridge is discarded when the growth hormone medication is exhausted. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10300130923796	GS1

Customer Contacts

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