FDA.reportPublic FDA data

Puritan® PurFlock Ultra®

Primary DI
10609576300018
Brand
Puritan® PurFlock Ultra®
Company
Puritan Medical Products
Model
3000-U E30
Catalog number
3000-U E30
Device description
Puritan® PurFlock Ultra® Flocked Collection Device
Published
2026-07-20
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
10609576300018PrimaryGS10
00609576300011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060957630001810609576300018
00609576300011006095763000116095763000110609576300011

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
true
Serial number
false
Manufacturing date on label
true
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
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
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
10609576331111Puritan® PurFlock Ultra®3317-U PRT3317-U PRT2026-07-20
10609576331418Puritan® HydraFlock®3206-H3206-H2026-07-20
10609576331432Puritan® HydraFlock®3317-H PRT BLACK3317-H PRT BLACK2026-07-20
10609576331449Puritan® HydraFlock®3317-H PRT RED3317-H PRT RED2026-07-20
10609576331586Puritan® PurFlock Ultra®3317-U NYL3317-U NYL2026-07-20
10609576340007Puritan® PurFlock Ultra®3406-U RING3406-U RING2026-07-20
10609576360203Puritan® HydraFlock®3316-H3316-H2026-07-20
10609576360210Puritan® HydraFlock®3317-H3317-H2026-07-20
10609576360241Puritan® PurFlock Ultra®3318-U3318-U2026-07-20
10609576360265Puritan® PurFlock Ultra®3406-U3406-U2026-07-20
10609576800068Puritan®826-WC826-WC2026-07-20
10609576800075Puritan®869-WCS869-WCS2026-07-20
10609576800297Puritan®868-WCS868-WCS2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
30609576801106Puritan®Puritan Medical ProductsKXF2026-07-20