FDA.reportPublic FDA data

LAMP (52VDC 50W)

Primary DI
00841034134589
Brand
LAMP (52VDC 50W)
Company
RPI
Model
LMP029
Catalog number
LMP029
Device description
BULB ONLY
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBIUnit, Neonatal Phototherapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBIUnit, Neonatal PhototherapyGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021531000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021531000RPI REPLACEMENT PHOTOTHERAPY LIGHTSReplacement Parts Industries, Inc.2002-05-31LBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841034134589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841034134589008410341345898410341345890841034134589

GMDN Terms#

Term, Definition table
TermDefinition
Blue-light phototherapy lamp, clinicalA 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 by a healthcare professional in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
818-882-8611techsupport@rpiparts.com

Regulatory Flags#

DUNS number
066232067
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841034110798ACQUISITION MODULE CABLEGEC020GEC0202016-12-09
00841034110804ACQUISITION MODULE CABLEGEC021GEC0212016-12-09
00841034112136TELEMETRY CABLE 2 LEAD SNKBB001KBB0012016-12-09
00841034112143PATIENT CABLE - 3 LEAD DNKCA001KCA0012016-12-09
00841034112150PATIENT CABLE - 3 LEAD DNKCA004KCA0042016-12-09
00841034112167PATIENT CABLE - 3 LEAD DNKCA007KCA0072016-12-09
00841034112174PATIENT CABLE - 3 LEAD DNKCA010KCA0102016-12-09
00841034112181PATIENT CABLE - 3 LEAD DNKCA013KCA0132016-12-09
00841034112198PATIENT CABLE - 3 LEAD DNKCA016KCA0162016-12-09
00841034112204PATIENT CABLE - 3 LEAD DNKCA019KCA0192016-12-09
00841034112211PATIENT CABLE - 3 LEAD DNKCA022KCA0222016-12-09
00841034112228PATIENT CABLE - 3 LEAD DNKCA025KCA0252016-12-09
00841034112235PATIENT CABLE - 3 LEAD DNKCA035KCA0352016-12-09
00841034112242PATIENT CABLE - 3 LD FX SNKCB002KCB0022016-12-09
00841034112259PATIENT CABLE - 3 LD FX SNKCB008KCB0082016-12-09
00841034112266TELEMETRY CABLE 3 LEAD SNKCB028KCB0282016-12-09
00841034112273TELEMETRY CABLE 3 LEAD SNKCB029KCB0292016-12-09
00841034112280TELEMETRY CABLE 3 LEAD SNKCB031KCB0312016-12-09
00841034112297TELEMETRY CABLE 3 LEAD PIKCB032KCB0322016-12-09
00841034112303PATIENT CABLE - 3 LD FX SNKCB036KCB0362016-12-09

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