FDA.reportPublic FDA data

SKATER™ Single Step Drainage Set

Primary DI
20886333000221
Brand
SKATER™ Single Step Drainage Set
Company
ARGON MEDICAL DEVICES, INC.
Model
756006025E
Catalog number
756006025
Device description
SKATER™ Single Step Drainage Set 6Fr x 25cm
Published
2022-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20886333000221PackageGS15In Commercial Distribution
00886333000227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300022120886333000221
00886333000227008863330002278863330002270886333000227

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainage kitA collection of devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
140727624
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00886333000036SKATER™ Drainage Catheter751107035E7511070352022-07-11
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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