FDA.reportPublic FDA data

Puritan

Primary DI
00609576380105
Brand
Puritan
Company
Puritan Medical Products
Model
25-806 1PD
Catalog number
25-806 1PD
Device description
Sterile Polyester Tipped Applicators
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
30609576380106PackageGS1100In Commercial Distribution
50609576380100PackageGS110In Commercial Distribution
60609576380107PackageGS11000In Commercial Distribution
00609576380105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3060957638010630609576380106
5060957638010050609576380100
6060957638010760609576380107
00609576380105006095763801056095763801050609576380105

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
30609576900137Puritan Opti-SwabLA-116 (3316-H)LA-116 (3316-H)2022-12-08
30609576900144Puritan Opti-SwabLA-117 (3317-H)LA-117 (3317-H)2022-12-08
30609576900151Puritan Opti-SwabLA-106 (3506-H)LA-106 (3506-H)2022-12-08
30609576900892Puritan Opti-SwabCB-206 (25-3506-H)CB-206 (25-3506-H)2022-12-08
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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