FDA.reportPublic FDA data

Polyester Spun Swab 4 Ct. Pouch

Primary DI
00850027193304
Brand
Polyester Spun Swab 4 Ct. Pouch
Company
Steripack (usa) Limited LLC
Model
60598
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
00850027193021PackageGS12000In Commercial Distribution
00850027193304PrimaryGS10
00850027193199Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850027193021008500271930218500271930210850027193021
00850027193304008500271933048500271933040850027193304
00850027193199008500271931998500271931990850027193199

GMDN Terms#

Term, Definition table
TermDefinition
Hu antibody (anti-Hu) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-Hu antibodies in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
042126640
Device count
4
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
00850027193311Polyester Spun Swab 500ct. Pouch606162022-10-03
00850027193328Polyester Spun Swab 25ct. Pouch606262022-10-03
00850027193335Polyester Spun Swab 50ct. Pouch606322022-10-03
00850027193397"Sterile 3"" Foam swab with yellow handle V2 100ct."606522022-10-03
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