FDA.reportPublic FDA data

Keystone Sterile Specimen Collection Flocked Swab - 6 inch

Primary DI
10860003793708
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
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013799942
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
false
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
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
00860003793701Keystone Sterile Specimen Collection Flocked Swab - 6 inchKMSWAB-600P1-1002021-08-17
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
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