FDA.reportPublic FDA data

Puritan HydraFlock

Primary DI
10609576330763
Brand
Puritan HydraFlock
Company
Puritan Medical Products
Model
25-3806-H BT
Catalog number
25-3806-H BT
Device description
Sterile Flocked Collection Devices
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
30609576330767PackageGS1100In Commercial Distribution
50609576330761PackageGS15In Commercial Distribution
10609576330763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3060957633076730609576330767
5060957633076150609576330761
1060957633076310609576330763

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10609576330770Puritan PurFlock Ultra25-3806-U BT25-3806-U BT2022-12-08
10609576330787Puritan PurFlock Ultra25-3316-H BT25-3316-H BT2022-12-08
10609576330794Puritan PurFlock Ultra25-3316-U BT25-3316-U BT2022-12-08
10609576330800Puritan HydraFlock25-3317-H BT25-3317-H BT2022-12-08
10609576330916Puritan HydraFlock25-3316-H EMB 80 BT25-3316-H EMB 80 BT2022-12-08
10609576330923Puritan HydraFlock25-3316-H EMB 100 BT25-3316-H EMB 100 BT2022-12-08
10609576330930Puritan PurFlock Ultra25-3316-U EMB 80 BT25-3316-U EMB 80 BT2022-12-08
10609576331166Puritan HydraFlock25-3706-H BT PK25-3706-H BT PK2022-12-08
10609576331197Puritan HydraFlock25-3206-H 20MM BT25-3206-H 20MM BT2022-12-08
10609576331241Puritan HydraFlock25-3319-H BT25-3319-H BT2022-12-08
10609576331340Puritan HydraFlock25-3806-H BT PK25-3806-H BT PK2022-12-08
10609576370783Puritan PurFlock Ultra25-3706-U BT25-3706-U BT2022-12-08
10609576381710Puritan25-1506 1PF BT BL25-1506 1PF BT BL2022-12-08
30609576900007Puritan UniTranz-RTUT-100UT-1002022-12-08
30609576900014Puritan UniTranz-RTUT-300UT-3002022-12-08
30609576900021Puritan UniTranz-RTUT-106UT-1062022-12-08
30609576900038Puritan UniTranz-RTUT-116UT-1162022-12-08
30609576900045Puritan UniTranz-RTUT-117UT-1172022-12-08
30609576900052Puritan UniTranz-RTUT-306UT-3062022-12-08
30609576900069Puritan UniTranz-RTUT-316UT-3162022-12-08

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