FDA.reportPublic FDA data

Firefly Luer Cover

Primary DI
00865349000339
Brand
Firefly Luer Cover
Company
PURACATH MEDICAL, INC
Model
40401
Device description
Luer Cap for the Firefly Transfer Catheter
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
Sterile
true
Single use
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
865349000346PackageGS18In Commercial Distribution
00865349000339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
865349000346008653490003468653490003460865349000346
00865349000339008653490003398653490003390865349000339

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter disinfection capA sterile (or with sterile fluid path) cap intended to be placed on one of the alternative connectors in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device.

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865349000353Firefly IPA Bottle405952016-11-21
00865349000308Firefly UV Disinfection Device404062016-11-21
00865349000315Firefly Transfer Catheter403982016-11-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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08964004471018Automated PD Set DS-1BYONYKS PRIVATE LIMITEDKDJ2025-09-08
08964004471025Automated PD Set DS-1BYONYKS PRIVATE LIMITEDKDJ2025-09-08
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20085412841629MINICAP EXTENDED LIFE PD TRNSBAXTER HEALTHCARE CORPORATIONKDJ2024-08-05
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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
00865349000308Firefly UV Disinfection DevicePURACATH MEDICAL, INCKDJ2016-11-21
00865349000315Firefly Transfer CatheterPURACATH 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