FDA.reportPublic FDA data

SKATER™ Drainage Catheter

Primary DI
00886333000104
Brand
SKATER™ Drainage Catheter
Company
ARGON MEDICAL DEVICES, INC.
Model
751114025E
Catalog number
751114025
Device description
SKATER™ Drainage Catheter Non- locking pigtail 14F x 25cm
Published
2022-07-12
Public version status
Update
Distribution status
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
GBQCatheter, Continuous Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBQCatheter, Continuous IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333000108PackageGS15In Commercial Distribution
00886333000104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300010820886333000108
00886333000104008863330001048863330001040886333000104

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and away from sunlight

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333226931Micro-Access Introducer4978374978372026-10-07
00886333226948Micro-Access Introducer4978394978392026-10-07
00886333004171V•Stick™ Vascular Access Set390204400E390204400E2016-09-16
00886333004188V•Stick™ Vascular Access Set391504000E391504000E2016-09-16
00886333004195V•Stick™ Vascular Access Set391504300E391504300E2016-09-16
00886333004201V•Stick™ Vascular Access Set391504400E391504400E2016-09-16
00886333004218V•Stick™ Vascular Access Set391504500E391504500E2016-09-16
00886333004225V•Stick™ Vascular Access Set391505000E391505000E2016-09-16
00886333004232V•Stick™ Vascular Access Set391505300E391505300E2016-09-16
00886333004249V•Stick™ Vascular Access Set391505400E391505400E2016-09-16
00886333004256V•Stick™ Vascular Access Set391505500E391505500E2016-09-16
00886333004263V•Stick™ Vascular Access Set391605300E391605300E2016-09-16
00886333004270V•Stick™ Vascular Access Set391604000E391604000E2016-09-16
00886333004287V•Stick™ Vascular Access Set391604300E391604300E2016-09-16
00886333004294V•Stick™ Vascular Access Set391604400E391604400E2016-09-16
00886333004300V•Stick™ Vascular Access Set391604500E391604500E2016-09-16
00886333004317V•Stick™ Vascular Access Set391605000E391605000E2016-09-16
00886333004324V•Stick™ Vascular Access Set391605400E391605400E2016-09-16
00886333004331V•Stick™ Vascular Access Set391605500E391605500E2016-09-16
00886333007042V•Stick™ Vascular Access Set391705400E391705400E2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886333006205Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006212Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006229Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006236Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006243Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006250Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006267Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006274Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006281Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006298Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006304Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006311Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006328Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006335Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006342Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333006359Skater All-Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333225514Skater All Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
00886333225521Skater All Purpose Drainage CatheterARGON MEDICAL DEVICES, INC.GBQ2026-10-07
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00849296015059WelmedWELMED INC.GBQ2026-02-15
00849296015066WelmedWELMED INC.GBQ2026-02-15
00849296015073WelmedWELMED INC.GBQ2026-02-15
00849296015080WelmedWELMED INC.GBQ2026-02-15
00849296018203WelmedWELMED INC.GBQ2026-02-15
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