FDA.reportPublic FDA data

Keystone Sterile Specimen Collection Flocked Swab - 6 inch

Primary DI
00860003793701
Brand
Keystone Sterile Specimen Collection Flocked Swab - 6 inch
Company
KEYSTONE MANUFACTURING, LLC
Model
KMSWAB-600P1-100
Device description
Absorbent Tipped Applicator, Sterile
Published
2021-08-17
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
10860003793708PackageGS1100In Commercial Distribution
00860003793701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000379370810860003793708
00860003793701008600037937018600037937010860003793701

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.

Regulatory Flags#

DUNS number
013799942
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860000906036MINNE TIES MT-1003MT-10032021-08-17
00860003793732Keystone VACUETTE 3ml Virus Stabilization Tube 1200 pcsKMVIAL-VAC3ML-12002021-08-17
00860003793749Keystone VACUETTE 2ml Virus Stabilization Tube 1200 pcsKMVIAL-VAC2ML-12002021-08-17
00860003793770Keystone Nasal / Respiratory Specimen Collection Kit – 100 packKMSVKIT-KM01-1002021-08-17
00860003793794Keystone Nasal / Respiratory Specimen Collection Kit – 100 packKMSVKIT-KM03-1002021-08-17
00860005748303Keystone Nasal / Respiratory Specimen Collection Kit – 100 packKMSVKIT-KM04-1002021-08-17
00860005748310Keystone Nasal / Respiratory Specimen Collection Kit – 100 packKMSVKIT-KM05-1002021-08-17
00860005748327Keystone Bartels FlexTrans Transport Medium 3mL Tube 1800pcsKMVIAL-VTM3ML-18002021-08-17
90860000906046Keystone Sterile Nasopharyngeal Tapered Swab - 6 inchKMSWAB-600T-1002021-08-17
90860000906060Keystone Sterile Nasopharyngeal Flocked Swab - 6 inchKMSWAB-600-1002021-08-17
90860000906084Keystone Sterile Nasopharyngeal Non-Tapered Swab - 6 inchKMSWAB-600P-1002021-08-17
00860003793718Keystone Sterile Specimen Collection Polyester Swab - 6 inchKMSWAB-806P-1002021-08-17
00860003793725Keystone Sterile Specimen Collection Flocked Swab - 5 inchKMSWAB-805P-1002021-08-17
00860003793756Keystone Sterile Specimen Collection Polyurethane Foam Swab - 6 inchKMSWAB-1406P-1002021-08-17
00860000906005MINNE TIES MT-1000MT-10002021-08-17
00860000906012MINNE TIES MT-1001MT-10012021-08-17
00860000906029MINNE TIES MT-1002MT-10022021-08-17
10860003793708Keystone Sterile Specimen Collection Flocked Swab - 6 inchKMSWAB-600P1-1002021-08-17
10860003793715Keystone Sterile Specimen Collection Polyester Swab - 6 inchKMSWAB-806P-1002021-08-17
10860003793722Keystone Sterile Specimen Collection Flocked Swab - 5 inchKMSWAB-805P-1002021-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00609576360251Puritan® Dry Transport System Sterile Flocked Collection DevicePuritan Medical ProductsKXG2026-05-29
38053326007027FLOQSwabs®COPAN ITALIA SPAKXG2026-03-20
08809262391039Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
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