LAMP (12VDC 100W) - 6

Basic Information

• Brand Name: LAMP (12VDC 100W) - 6
• Primary DI: 00841034134572
• Version / Model: LMP028
• Catalog Number: LMP028
• Company Name: RPI
• Labeler DUNS: 066232067
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-12-09
• Public Version: 5
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: 301a2ff6-0b1d-4c81-8560-05b5d4c1e3e6

Device Description

BULB ONLY

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBI	Unit, Neonatal Phototherapy	General Hospital	880.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61721	Blue-light phototherapy lamp, professional	A portable, electrically-powered device designed to emit blue light (e.g., 400-470nm) for phototherapy applications, alone or in conjunction with a photoconverter gel (not included), to treat skin diseases such as acne, rosacea, and psoriasis, and/or to promote wound healing. It is intended to be used exclusively by a healthcare professional in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841034134572	GS1
Unit of Use	00841034136880	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021531	000