FDA.reportPublic FDA data

Puritan HydraFlock

Primary DI
00609576330339
Brand
Puritan HydraFlock
Company
Puritan Medical Products
Model
25-3318-H
Catalog number
25-3318-H
Device description
Sterile Flocked Collection Devices
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
30609576010409PackageGS124In Commercial Distribution
30609576330330PackageGS150In Commercial Distribution
50609576330334PackageGS110In Commercial Distribution
00609576330339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3060957601040930609576010409
3060957633033030609576330330
5060957633033450609576330334
00609576330339006095763303396095763303390609576330339

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.

Contacts#

Phone, Email table
PhoneEmail
800-321-2313sales@puritanmedproducts.com

Regulatory Flags#

DUNS number
001101419
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
00609576381164Puritan®25-806 2WC TT FDNA25-806 2WC TT FDNA2026-07-31
10609576801294Hospital®803-WC HOSPITAL803-WC HOSPITAL2026-07-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00609576381164Puritan®Puritan Medical ProductsKXG2026-07-31
10609576901789QuickVuePuritan Medical ProductsKXG2026-07-31
30609576380618Hospital®Puritan Medical ProductsKXG2026-07-31
00609576381119Puritan®Puritan Medical ProductsKXG2026-07-27
00609576381133Puritan®Puritan Medical ProductsKXG2026-07-27
00609576381423Puritan®Puritan Medical ProductsKXG2026-07-27
00609576381676Puritan®Puritan Medical ProductsKXG2026-07-27
00609576901799Puritan®Puritan Medical ProductsKXG2026-07-27
30609576381196Puritan®Puritan Medical ProductsKXG2026-07-27
30609576380601Hospital®Puritan Medical ProductsKXG2026-07-20
30609576380809Puritan®Puritan Medical ProductsKXG2026-07-20
50609576901701cobas Dual SwabsPuritan Medical ProductsKXG2026-07-20
00810124537616VaklyAvaline Medical NJ Limited Liability CompanyKXG2026-07-16
00609576010132BD AffirmPuritan Medical ProductsKXG2026-07-08
00609576381539Puritan®Puritan Medical ProductsKXG2026-07-08
00609576381782Puritan®Puritan Medical ProductsKXG2026-07-08
00609576390302Puritan®Puritan Medical ProductsKXG2026-07-08
10609576380362Puritan®Puritan Medical ProductsKXG2026-07-08
10609576381413Puritan®Puritan Medical ProductsKXG2026-07-08
00884999051737RealTimeABBOTT MOLECULAR INC.KXG2026-07-06
00884999051744Alinity mABBOTT MOLECULAR INC.KXG2026-07-06
00609576010378BD ProbeTecPuritan Medical ProductsKXG2026-07-02
00609576390142PuritanPuritan Medical ProductsKXG2026-07-02
00609576360251Puritan® Dry Transport System Sterile Flocked Collection DevicePuritan Medical ProductsKXG2026-05-29
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