FDA.reportPublic FDA data

Swabeze

Primary DI
00817522013360
Brand
Swabeze
Company
KENTEC MEDICAL, INC.
Model
KMI-74
Catalog number
KMI-74
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
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817522013364PackageGS1300In Commercial Distribution
30817522013361PackageGS13600In Commercial Distribution
00817522013360PrimaryGS10
10817522013367Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081752201336420817522013364
3081752201336130817522013361
00817522013360008175220133608175220133600817522013360
1081752201336710817522013367

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.

Regulatory Flags#

DUNS number
066175613
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817522010250Kentec ArmBoard403AB403AB2021-12-16
10817522010267Kentec ArmBoard403ABV403ABV2021-12-16
10817522010298Kentec ArmBoard404ABV404ABV2021-12-16
10817522010311Kentec ArmBoard405AB405AB2021-12-16
10817522010328Kentec ArmBoard405ABV405ABV2021-12-16
10817522010281Kentec ArmBoard404AB404AB2021-12-16
10817522010694Ameritus TransducerATG200-TATG200-T2016-09-21
00817522013377SwabezeKMI-40KMI-402024-06-28
20817522013371SwabezeKMI-40KMI-402024-06-28
00817522013353SwabezeKMI-65KMI-652024-06-27
00817522013384SwabezeKMI-111KMI-1112024-06-27
20817522013357SwabezeKMI-65KMI-652024-06-27
20817522013364SwabezeKMI-74KMI-742024-06-27
20817522013388SwabezeKMI-111KMI-1112024-06-27
10817522013343SwabezeKMI-LAKMI-LA2024-06-20
20817522013340SwabezeKMI-LAKMI-LA2024-06-20
10817522010359AmeritusAMG-503-LGAMG-503-LG2016-08-01
10817522010366AmeritusAMG-503-SMAMG-503-SM2016-08-01
10817522013336Kentec electrodeAMG-503-PEDAMG-503-PED2024-04-25
20817522010356AmeritusAMG-503-LGAMG-503-LG2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483563267BALLARD™SUNMED, LLCKXF2026-01-12
10889483563281BALLARD™SUNMED, LLCKXF2026-01-12
10889483563311BALLARD™SUNMED, LLCKXF2026-01-12
10889483563335BALLARD™SUNMED, LLCKXF2026-01-12
10889483563359BALLARD™SUNMED, LLCKXF2026-01-12
07613327680720Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
10889483563274BALLARD™SUNMED, LLCKXF2025-11-17
10889483563298BALLARD™SUNMED, LLCKXF2025-11-17
10889483563328BALLARD™SUNMED, LLCKXF2025-11-17
10889483563342BALLARD™SUNMED, LLCKXF2025-11-17
10889483565520BALLARD™SUNMED, LLCKXF2025-11-17
10889483565537BALLARD™SUNMED, LLCKXF2025-11-17
10889483565544BALLARD™SUNMED, LLCKXF2025-11-17
M220761002Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXF2025-09-11
D832600BA4001MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BF4001MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BR4001MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
10840330701454ProCureTwin Med, LLCKXF2024-11-14
10840330701461ProCureTwin Med, LLCKXF2024-11-14
10840330701478ProCureTwin Med, LLCKXF2024-11-14
10840330701485ProCureTwin Med, LLCKXF2024-11-14
00616784430713"DynaSafety Cotton-Tipped Applicators in Sealed Vial,3"""Dynarex CorporationKXF2024-11-11
00087701406973Good NeighborU.S. COTTON, LLCKXF2024-07-30
00817522013377SwabezeKENTEC MEDICAL, INC.KXF2024-06-28
00817522013353SwabezeKENTEC MEDICAL, INC.KXF2024-06-27
00817522013384SwabezeKENTEC MEDICAL, INC.KXF2024-06-27
10817522013343SwabezeKENTEC MEDICAL, INC.KXF2024-06-20