FDA.reportPublic FDA data

Hospital®

Primary DI
10609576801294
Brand
Hospital®
Company
Puritan Medical Products
Model
803-WC HOSPITAL
Catalog number
803-WC HOSPITAL
Device description
Hospital® Cotton Tipped Applicators
Published
2026-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
30609576801298PackageGS110In Commercial Distribution
50609576801292PackageGS110In Commercial Distribution
10609576801294PrimaryGS10
00609576801297Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3060957680129830609576801298
5060957680129250609576801292
1060957680129410609576801294
00609576801297006095768012976095768012970609576801297

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
001101419
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
00609576381164Puritan®25-806 2WC TT FDNA25-806 2WC TT FDNA2026-07-31
10609576901789QuickVue25-1506 1PFB TT 2017125-1506 1PFB TT 201712026-07-31
30609576380618Hospital®25-806 2WC HOSPITAL25-806 2WC HOSPITAL2026-07-31
30609576901943Puritan® UniTranz-RT®UT-300 RBUT-300 RB2026-07-31
00609576381119Puritan®25-806 2PC YELLOW25-806 2PC YELLOW2026-07-27
00609576381133Puritan®25-806 2PC PINK25-806 2PC PINK2026-07-27
00609576381423Puritan®25-806 1PD BT25-806 1PD BT2026-07-27
00609576381676Puritan®25-806 10WCL25-806 10WCL2026-07-27
00609576901799Puritan®25-806 2PC WHITE25-806 2PC WHITE2026-07-27
30609576381196Puritan®25-806 2PR TT25-806 2PR TT2026-07-27
50609576700274Puritan®711-FS711-FS2026-07-27
00609576010378BD ProbeTec25-44135725-4413572026-07-02
00609576700095Puritan®710 CHERRY710 CHERRY2026-07-20
00609576700101Puritan®710 STRAWBERRY710 STRAWBERRY2026-07-20
00609576700118Puritan®710 GRAPE710 GRAPE2026-07-20
10609576150064Puritan®1506-PFB DM1506-PFB DM2026-07-20
10609576300018Puritan® PurFlock Ultra®3000-U E303000-U E302026-07-20
10609576330657Puritan® PurFlock Ultra®3316-U EMB 79MM RING3316-U EMB 79MM RING2026-07-20
10609576330725Puritan® PurFlock Ultra®3806-U EMB 79.5MM3806-U EMB 79.5MM2026-07-20
10609576331098Puritan® PurFlock Ultra®3406-U RING PRT3406-U RING PRT2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10609576300018Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576330657Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576330725Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576331098Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576331111Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576331418Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331432Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331449Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331586Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576340007Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576360203Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576360210Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576360241Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576360265Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576800068Puritan®Puritan Medical ProductsKXF2026-07-20
10609576800075Puritan®Puritan Medical ProductsKXF2026-07-20
10609576800297Puritan®Puritan Medical ProductsKXF2026-07-20
10609576800570Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800024Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800048Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800055Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800109Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800130Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800161Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800185Puritan® CalgiSwab®Puritan Medical ProductsKXF2026-07-20
30609576800208Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800406Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800543Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800604Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800734Puritan®Puritan Medical ProductsKXF2026-07-20