FDA.reportPublic FDA data

First+Aid

Primary DI
10048341010774
Brand
First+Aid
Company
U.S. COTTON, LLC
Model
S FPDLRS 0100 R02401 FBB
Catalog number
S FPDLRS 0100 R02401 FBB
Device description
Sterile Cotton Swabs (100ct)
Published
2020-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
10048341010774PackageGS124In Commercial Distribution
00048341010777PrimaryGS10
10048341800115Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004834101077410048341010774
00048341010777000483410107770483410107770048341010777
1004834180011510048341800115

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 made of wood, paper, or plastic, 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 to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is used in a healthcare setting and in the home. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store indoors under normal ambient conditions in sealed package

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-321-1029e.sales@uscotton.com

Regulatory Flags#

DUNS number
932938897
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00048341007029First+AidS SDDLR 0125 R03606 FAB [was S SDDLR 0125 R03606 FS SDDLR 0125 R03606 FAB2020-02-28
00048341007012First+AidB GRDL 0300 R03606 FAB [was B GRDL 0300 R03606 FBBB GRDL 0300 R03606 FAB2020-02-28
00087701406973Good NeighborS BPDLR 0375 R04801 GD2024-07-30
10048341800146Good NeighborS BPDLR 0375 R04801 GD2024-07-30
00087701485718Good NeighborB FMDLS 0130 R02401 GD2020-02-28
00095859105006U.S. CottonB FMDLS 0500 R01201 USB FMDLS 0500 R01201 US2020-02-28
00096295134476LeaderB FMDLS 0130 R02406 LEA2020-02-28
00048341007135First+AidB FMDLS 0130 R02406 FAB [was B FMDLS 0130 R02406 FB FMDLS 0130 R02406 FAB2020-02-28
00048341011842FischerbrandB PLDL 1000 R00201 AC2020-02-28
00095859110000U.S. CottonB PJDL 1000 R00201 USB PJDL 1000 R00201 US2020-02-28
00095859120009U.S. CottonB PMDL 2000 R00201 USB PMDL 2000 R00201 US2021-02-13
00095859110505U.S. CottonB PXDL 0500 R00401 USB PXDL 0500 R00401 US2020-02-28
00041520863904CareOneB FMDLS 0130 R03606 AHL2020-02-28
00036800186101TopCareB FMDLS 0130 R03606 TPC2020-02-28
00095859100063U.S. CottonL GLUS 0001 R02501 USL GLUS 0001 R02501 US2020-02-28
00095859603106U.S. CottonL GLDL 0001 R01201 USL GLDL 0001 R01201 US2020-02-28
00048341011835FischerbrandB PMDL 2000 R00201 FH2021-02-13
00095859100162U.S. CottonL FZUSS 0160 R01201 USL FZUSS 0160 R01201 US2020-02-28
00048341007111First+AidL FZUSS 0040 R02401 FAB [was L FZUSS 0040 R02401 FL FZUSS 0040 R02401 FAB2020-02-28
00041415009684PublixB FMDLS 0130 R02401 PB2020-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809262394221Specimen Collection SwabHLB CO.,LTDKXG2025-10-28