FDA.reportPublic FDA data

"Sterile 3"" Foam swab with yellow handle V2 100ct."

Primary DI
00850027193397
Brand
"Sterile 3"" Foam swab with yellow handle V2 100ct."
Company
Steripack (usa) Limited LLC
Model
60652
Device description
single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares
Published
2022-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850027193182PackageGS11700In Commercial Distribution
00850027193397PrimaryGS10
00850027193366Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850027193182008500271931828500271931820850027193182
00850027193397008500271933978500271933970850027193397
00850027193366008500271933668500271933660850027193366

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
042126640
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850027193038XpressCollect TM Sterile Polyester Spun Swab in Tube 1 ea.606002022-10-03
00850027193045XpressCollect TM Sterile Polyester Spun Swab in Tube 100 ea.606012022-10-03
00850027193106Sterile 3” Foam Swab with yellow handle V2606122022-10-03
00850027193120Sterile 3” Sterile Flocked Swab with blue handle606142022-10-03
00850027193137Sterile 3” Sterile Flocked Swab with white handle606152022-10-03
00850027193229Sterile Polyester Spun Swab 10 Pack605782022-10-03
00850027193236Sterile Polyester Spun Swab 20 Pack605892022-10-03
00850027193243Sterile Polyester Spun Swab 25 Ct. Pouch605942022-10-03
00850027193267Sterile Narrow Polyester Spun Swab 25 Pack605792022-10-03
00850027193274Sterile Narrow Polyester Spun Swab V2 25 Pack605802022-10-03
00850027193281Polyester Spun Swab 28 Ct. Pouch605952022-10-03
00850027193298Polyester Spun Swab 200 Ct. Pouch605962022-10-03
00850027193304Polyester Spun Swab 4 Ct. Pouch605982022-10-03
00850027193311Polyester Spun Swab 500ct. Pouch606162022-10-03
00850027193328Polyester Spun Swab 25ct. Pouch606262022-10-03
00850027193335Polyester Spun Swab 50ct. Pouch606322022-10-03
00860004112723Sterile Narrow Polyester Spun Swab605672022-10-03
00860004112754Sterile Narrow Polyester Spun Swab V2605772022-10-03
00850027193342XpressCollect TM Sterile Polyester Spun Swab in Tube 1 ea.606002022-10-03
00850027193359XpressCollect TM Sterile Polyester Spun Swab in Tube 100 ea.606012022-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
38053326007027FLOQSwabs®COPAN ITALIA SPAKXG2026-03-20
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08809262391053Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391060Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391077Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391329Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391336Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391343Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391350Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391367Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391374Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391527Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391534Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262392104Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394030Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394047Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394061Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394078Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394085Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394092Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394115Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394122Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394139Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394146Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394153Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394177Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394191Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394207Specimen Collection swabHLB CO.,LTDKXG2025-10-28
08809262394214Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394221Specimen Collection SwabHLB CO.,LTDKXG2025-10-28