FDA.reportPublic FDA data

Puritan

Primary DI
10609576381710
Brand
Puritan
Company
Puritan Medical Products
Model
25-1506 1PF BT BL
Catalog number
25-1506 1PF BT BL
Device description
Sterile Foam Tipped Applicators
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
30609576381714PackageGS1100In Commercial Distribution
50609576381718PackageGS15In Commercial Distribution
10609576381710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3060957638171430609576381714
5060957638171850609576381718
1060957638171010609576381710

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
00609576390142Puritan25-1503 1PFB SOLID25-1503 1PFB SOLID2026-07-02
00609576010330Puritan25-1506 1PFB25-1506 1PFB2022-12-08
00609576340031Puritan HydraFlock25-3406-H25-3406-H2022-12-08
00609576380037Puritan25-806 1WC25-806 1WC2022-12-08
00609576380105Puritan25-806 1PD25-806 1PD2022-12-08
00609576010132BD Affirm25-806 1PRB BD25-806 1PRB BD2026-07-08
00609576381539Puritan®25-806 1PDS BINAX25-806 1PDS BINAX2026-07-08
00609576381782Puritan®25-806 1PRB 250/10 UNB25-806 1PRB 250/10 UNB2026-07-08
00609576390302Puritan®25-806 1PRB 80/3025-806 1PRB 80/302026-07-08
00609576901515Puritan® OptiSwab®LA-106 USLA-106 US2026-07-08
00609576901713Puritan® OptiSwab®LA-117 BCLA-117 BC2026-07-08
00609576901775Puritan® OptiSwab®LA-106 BCLA-106 BC2026-07-08
00609576901911PurSafe+PSP-106PSP-1062026-07-08
00609576901928PurSafe+PSP-116PSP-1162026-07-08
00609576901935PurSafe+PSP-120PSP-1202026-07-08
10609576380362Puritan®25-806 1PDB SLD ABON25-806 1PDB SLD ABON2026-07-08
10609576381413Puritan®25-806 1WC BT25-806 1WC BT2026-07-08
00609576010347Puritan25-1506 1PFB SLD 2025-1506 1PFB SLD 202022-12-08
00609576390180Puritan25-1406 1PF 5025-1406 1PF 502022-12-08
00609576330339Puritan HydraFlock25-3318-H25-3318-H2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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