FDA.reportPublic FDA data

SKATER™ Single Step Drainage Set

Primary DI
00886333000258
Brand
SKATER™ Single Step Drainage Set
Company
ARGON MEDICAL DEVICES, INC.
Model
756008020E
Catalog number
756008020
Device description
SKATER™ Single Step Drainage Set 8F x 20cm
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
20886333000252PackageGS15In Commercial Distribution
00886333000258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300025220886333000252
00886333000258008863330002588863330002580886333000258

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

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
00886333003594Breast Localization Needles231075G231075G2022-07-05
00886333003600Breast Localization Needles231030G231030G2022-07-05
00886333003617Breast Localization Needles231050G231050G2022-07-05
00886333003624Breast Localization Needles231125G231125G2022-07-05
00886333003631Breast Localization Needles231100G231100G2022-07-05
00886333003648Breast Localization Needles2420502420502022-06-30
00886333003655Breast Localization Needles2420752420752022-06-30
00886333003662Breast Localization Needles2421002421002022-06-30
00886333003679Breast Localization Needles2421252421252022-06-29
00886333003686Breast Localization Needles2430752430752022-06-29
00886333003693Breast Localization Needles2431252431252022-07-05
00886333003709Breast Localization Needles2430502430502022-06-29
00886333003723Breast Localization Needles2430302430302022-06-29
00886333003730Breast Localization Needles2440302440302022-06-30
00886333003747Breast Localization Needles2440502440502022-06-30
00886333003754Breast Localization Needles2440752440752022-06-29
00886333003761Breast Localization Needles2441002441002022-06-30
00886333003778Breast Localization Needles2441252441252022-06-30
00886333003785Breast Localization Needles2511002511002022-06-29
00886333003792Breast Localization Needles2510752510752022-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849296009898WelmedWELMED INC.GBQ2026-02-15
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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