FDA.reportPublic FDA data

First+Aid

Primary DI
00048341007029
Brand
First+Aid
Company
U.S. COTTON, LLC
Model
S SDDLR 0125 R03606 FAB [was S SDDLR 0125 R03606 F
Catalog number
S SDDLR 0125 R03606 FAB
Device description
Cotton Swabs (125ct)
Published
2020-02-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10048341007026PackageGS136Not in Commercial Distribution
00048341007029PrimaryGS10
10048341800122Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004834100702610048341007026
00048341007029000483410070290483410070290048341007029
1004834180012210048341800122

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.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
932938897
Device count
125
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00048341007104First+AidL FZUSS 0005 R07201 FAB [was L FZUSS 0005 R07201 FL FZUSS 0005 R07201 FAB2020-02-28

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