FOLLISTIM PEN STARTER KIT SAM USA

Basic Information

• Brand Name: FOLLISTIM PEN STARTER KIT SAM USA
• Primary DI: 00300520311533
• Version / Model: 1746811
• Company Name: Merck Sharp & Dohme LLC
• Labeler DUNS: 101740835
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-28
• Public Version: 4
• Public Version Date: 2024-01-01
• Public Version Status: Update
• Public Device Record Key: 25bbf343-06a1-4a7b-8c56-9fd255750032
• Distribution End Date: 2023-12-31

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
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
44127	Autoinjector needle	A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	60300520311535	GS1	box	12	Not in Commercial Distribution	2023-12-31
Primary	00300520311533	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	29	Gauge
Device Size Text, specify			reusable pen injector
Device Size Text, specify			needles
Length	6.25	Inch