Immucise

Basic Information

• Brand Name: Immucise
• Primary DI: 34987892133030
• Version / Model: IE-N102US
• Company Name: TERUMO CORPORATION
• Labeler DUNS: 690543319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-06-20
• Public Version: 1
• Public Version Date: 2025-06-30
• Public Version Status: New
• Public Device Record Key: 0fca0fc9-ae49-4a1a-a295-9bc902a3f08e

Device Description

Immucise Intradermal Injection Needle

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• PM Exempt: No
• Has Serial Number: No
• 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
FMI	Needle, hypodermic, single lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63095	General-purpose syringe/needle	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	54987892133034	GS1		12	In Commercial Distribution
Primary	34987892133030	GS1
Unit of Use	04987892133039	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	1.15	Millimeter
Needle Gauge	33	Gauge

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at temperature between 2 and 50 Celcius Degrees.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and keep away from sunlight.