BCG Vaccine (Multiple Puncture Device)

Basic Information

• Brand Name: BCG Vaccine (Multiple Puncture Device)
• Primary DI: 00300858999991
• Version / Model: 1039922
• Company Name: Merck Sharp & Dohme LLC
• Labeler DUNS: 101740835
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-10
• Public Version: 2
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: d3018e01-0d77-45ff-a104-62f9f212d6e9

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDH	SYSTEM, DELIVERY, ALLERGEN AND VACCINE

GMDN Terms

Code	Name	Definition	Implantable	Status
45539	Allergy testing lancet	A sterile device with a sharp triangular cutting edge at the distal end designed to manually breach the epidermis to facilitate the diagnosis of allergic reactions in skin allergy testing performed by an allergist or other healthcare professional. It is held between the fingertips and pressed transiently, but firmly (not jabbed), at right angles through a drop of an allergen extract into the flexor side of the forearm of a suspected allergic individual. The tip penetrates only the most superficial layers of the skin allowing a small volume of the allergen extract to enter the skin and diffuse into the skin layers below. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	60300858999993	GS1	box	1	In Commercial Distribution
Primary	00300858999991	GS1

Customer Contacts

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