Home GUDID 20817522013357 Swabeze
Primary DI 20817522013357
Brand Swabeze
Company KENTEC MEDICAL, INC.
Model KMI-65
Catalog number KMI-65
Device description foam swab
Published 2024-06-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name KXF Applicator, Absorbent Tipped, Non-Sterile
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20817522013357 Package GS1 300 In Commercial Distribution 30817522013354 Package GS1 33600 In Commercial Distribution 00817522013353 Primary GS1 0 10817522013350 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20817522013357 20817522013357 30817522013354 30817522013354 00817522013353 00817522013353 817522013353 0817522013353 10817522013350 10817522013350
GMDN Terms# Term, Definition table Term Definition General-purpose absorbent tip applicator/swab, single-use A 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 066175613 Device count 50 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10889483563267 BALLARD™ SUNMED, LLC KXF 2026-01-12 10889483563281 BALLARD™ SUNMED, LLC KXF 2026-01-12 10889483563311 BALLARD™ SUNMED, LLC KXF 2026-01-12 10889483563335 BALLARD™ SUNMED, LLC KXF 2026-01-12 10889483563359 BALLARD™ SUNMED, LLC KXF 2026-01-12 07613327680720 Q-Care SAGE PRODUCTS, LLC KXF 2025-12-03 07613327680737 Q-Care SAGE PRODUCTS, LLC KXF 2025-12-03 07613327680744 Q-Care SAGE PRODUCTS, LLC KXF 2025-12-03 07613327680751 Q-Care SAGE PRODUCTS, LLC KXF 2025-12-03 10889483563274 BALLARD™ SUNMED, LLC KXF 2025-11-17 10889483563298 BALLARD™ SUNMED, LLC KXF 2025-11-17 10889483563328 BALLARD™ SUNMED, LLC KXF 2025-11-17 10889483563342 BALLARD™ SUNMED, LLC KXF 2025-11-17 10889483565520 BALLARD™ SUNMED, LLC KXF 2025-11-17 10889483565537 BALLARD™ SUNMED, LLC KXF 2025-11-17 10889483565544 BALLARD™ SUNMED, LLC KXF 2025-11-17 M220761002 Pro Advantage NATIONAL DISTRIBUTION & CONTRACTING, INC. KXF 2025-09-11 D832600BA4001 MAXAPPLICATOR II PLASDENT CORPORATION KXF 2025-08-01 D832600BF4001 MAXAPPLICATOR II PLASDENT CORPORATION KXF 2025-08-01 10840330701454 ProCure Twin Med, LLC KXF 2024-11-14 10840330701461 ProCure Twin Med, LLC KXF 2024-11-14 10840330701478 ProCure Twin Med, LLC KXF 2024-11-14 10840330701485 ProCure Twin Med, LLC KXF 2024-11-14 00616784430713 "DynaSafety Cotton-Tipped Applicators in Sealed Vial,3""" Dynarex Corporation KXF 2024-11-11 00087701406973 Good Neighbor U.S. COTTON, LLC KXF 2024-07-30 00817522013377 Swabeze KENTEC MEDICAL, INC. KXF 2024-06-28 00817522013353 Swabeze KENTEC MEDICAL, INC. KXF 2024-06-27 00817522013360 Swabeze KENTEC MEDICAL, INC. KXF 2024-06-27 00817522013384 Swabeze KENTEC MEDICAL, INC. KXF 2024-06-27 10817522013343 Swabeze KENTEC MEDICAL, INC. KXF 2024-06-20