FDA.reportPublic FDA data

Firefly UV Disinfection Device

Primary DI
00865349000308
Brand
Firefly UV Disinfection Device
Company
PURACATH MEDICAL, INC
Model
40406
Device description
Battery powered Ultraviolet light disinfection device.
Published
2016-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDJSet, Administration, For Peritoneal Dialysis, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDJSet, Administration, For Peritoneal Dialysis, DisposableGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865349000308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865349000308008653490003088653490003080865349000308

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis system irradiation unitA mains electricity (AC-powered) device designed to emit ultraviolet radiation in order to keep the field and devices sterile while the appropriate connections between the components of a peritoneal dialysis transfer tubing set are implemented.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6505590388info@puracath.com

Regulatory Flags#

DUNS number
963236661
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865349000339Firefly Luer Cover404012016-11-21
00865349000353Firefly IPA Bottle405952016-11-21
00865349000315Firefly Transfer Catheter403982016-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414208011FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTIONVantive US Healthcare LLCKDJ2026-01-30
07332414208264MinicapVantive US Healthcare LLCKDJ2026-01-30
57332414208016FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTIONVantive US Healthcare LLCKDJ2026-01-30
57332414208269MinicapVantive US Healthcare LLCKDJ2026-01-30
08964004471032Automated PD Set DS-1.BBYONYKS PRIVATE LIMITEDKDJ2025-11-13
08964004471049Automated PD Set DS-1.BBYONYKS PRIVATE LIMITEDKDJ2025-11-13
07332414207946LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETERVantive US Healthcare LLCKDJ2025-09-23
27332414207940LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETERVantive US Healthcare LLCKDJ2025-09-23
08964004471018Automated PD Set DS-1BYONYKS PRIVATE LIMITEDKDJ2025-09-08
08964004471025Automated PD Set DS-1BYONYKS PRIVATE LIMITEDKDJ2025-09-08
07332414207939CYCLER DRAINAGE BAGBAXTER HEALTHCARE CORPORATIONKDJ2025-03-20
57332414207934CYCLER DRAINAGE BAGBAXTER HEALTHCARE CORPORATIONKDJ2025-03-20
00085412841625MINICAP EXTENDED LIFE PD TRNSBAXTER HEALTHCARE CORPORATIONKDJ2024-08-05
20085412841629MINICAP EXTENDED LIFE PD TRNSBAXTER HEALTHCARE CORPORATIONKDJ2024-08-05
00085412722894Cycler Drainage BagBAXTER HEALTHCARE CORPORATIONKDJ2022-09-23
50085412722899Cycler Drainage BagBAXTER HEALTHCARE CORPORATIONKDJ2022-09-23
00085412656021MiniCapBAXTER HEALTHCARE CORPORATIONKDJ2019-07-22
50085412656026MiniCapBAXTER HEALTHCARE CORPORATIONKDJ2019-07-22
00840861102037Cycler Drain Bag SetFresenius Medical Care Holdings, Inc.KDJ2019-06-11
00085412007748MiniCapBAXTER HEALTHCARE CORPORATIONKDJ2017-12-21
50085412007743MiniCapBAXTER INTERNATIONAL INC.KDJ2017-12-21
10887488321462CARDINAL HEALTHCardinal Health 200, LLCKDJ2017-05-01
50887488321460CARDINAL HEALTHCardinal Health 200, LLCKDJ2017-05-01
00865349000315Firefly Transfer CatheterPURACATH MEDICAL, INCKDJ2016-11-21
00865349000339Firefly Luer CoverPURACATH MEDICAL, INCKDJ2016-11-21
00865349000353Firefly IPA BottlePURACATH MEDICAL, INCKDJ2016-11-21
00898021000051Alcavis 50Angelini Pharma Inc.KDJ2016-08-29
00898021000044Alcavis 50Angelini Pharma Inc.KDJ2016-08-29
20898021000055Alcavis 50ANGELINI PHARMA INC.KDJ2016-08-29
00827002089754TenckhoffCOOK INCORPORATEDKDJ2015-10-24