easypod

Basic Information

• Brand Name: easypod
• Primary DI: 04054839025860
• Version / Model: U1222102
• Company Name: EMD SERONO, INC.
• Labeler DUNS: 088514898
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-11
• Public Version: 2
• Public Version Date: 2022-10-19
• Public Version Status: Update
• Public Device Record Key: f2f61da2-e974-44f3-a071-745c07c68b40
• Distribution End Date: 2022-10-18

Device Description

easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]) in cartridges.

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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
45819	Cartridge-accepting autoinjector, electronic	A portable, hand-held, battery-powered device 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 is replaced once the pharmaceutical is exhausted; the needle is replaced for each administration. The device includes an electronic display and may be capable of a variety of dose-recording functions. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04054839025860	GS1

Customer Contacts

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