FDA.reportPublic FDA data

SKATER™ Drainage Catheter

Primary DI
00886333000036
Brand
SKATER™ Drainage Catheter
Company
ARGON MEDICAL DEVICES, INC.
Model
751107035E
Catalog number
751107035
Device description
SKATER™ Drainage Catheter Non-locking pigtail 7F x 35cm
Published
2022-07-11
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
20886333000030PackageGS15In Commercial Distribution
00886333000036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300003020886333000030
00886333000036008863330000368863330000360886333000036

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
00886333210893Guidewire3951263951262016-09-21
00886333001408Skin Fix8025000008025000002022-07-14
00886333217618Skater™ Fix8025000018025000012022-07-14
00886333226320Co-Axial Introducer NeedleMCXS1620BXMCXS1620BX2022-07-21
00886333000005SKATER™ Drainage Catheter751106025E7511060252022-07-11
00886333000012SKATER™ Drainage Catheter751106035E7511060352022-07-12
00886333000029SKATER™ Drainage Catheter751107025E7511070252022-07-12
00886333000043SKATER™ Drainage Catheter751108025E7511080252022-07-11
00886333000067SKATER™ Drainage Catheter751110025E7511100252022-07-12
00886333000074SKATER™ Drainage Catheter751110035E7511100352022-07-12
00886333000081SKATER™ Drainage Catheter751112025E7511120252022-07-13
00886333000098SKATER™ Drainage Catheter751112035E7511120352022-07-12
00886333000104SKATER™ Drainage Catheter751114025E7511140252022-07-12
00886333000111SKATER™ Drainage Catheter755106025E7551060252022-07-13
00886333000128SKATER™ Drainage Catheter755106035E7551060352022-07-12
00886333000135SKATER™ Drainage Catheter755107025E7551070252022-07-13
00886333000142SKATER™ Drainage Catheter755107035E7551070352022-07-12
00886333000159SKATER™ Drainage Catheter755108025E7551080252022-07-12
00886333000166SKATER™ Drainage Catheter 755108035E7551080352022-07-13
00886333000173SKATER™ Drainage Catheter755110025E7551100252022-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849296009898WelmedWELMED INC.GBQ2026-02-15
00849296009911WelmedWELMED INC.GBQ2026-02-15
00849296014939WelmedWELMED INC.GBQ2026-02-15
00849296014946WelmedWELMED INC.GBQ2026-02-15
00849296015035WelmedWELMED INC.GBQ2026-02-15
00849296015042WelmedWELMED INC.GBQ2026-02-15
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
00849296018210WelmedWELMED INC.GBQ2026-02-15
00840106905102PERMA PUREPERMA PURE LLCGBQ2024-11-05
00886333220977Drainage BagARGON MEDICAL DEVICES, INC.GBQ2022-07-20
20886333220971Drainage BagARGON MEDICAL DEVICES, INC.GBQ2022-07-20
00886333227198SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227204SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227211SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227228SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227235SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227242SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227259SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
00886333227266SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227192SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227208SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227215SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227222SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227239SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227246SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14
20886333227253SKATER™ All Purpose and Nephrostomy Drainage SetARGON MEDICAL DEVICES, INC.GBQ2022-07-14