FDA.reportPublic FDA data

MARK3

Primary DI
D7962006
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
2006CS
Device description
Cotton Tipped Applicators 6" 10,000/CS - MARK3
Published
2021-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
D79620060PrimaryHIBCC0
D7962006CS1PrimaryHIBCC0
D7962006Unit of UseHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry place.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
096191093
Device count
10000
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014374983MARK3®597259722026-02-05
00850014374990MARK3®597459742026-02-05
00850014374648MARK3863-014C863-014C2025-10-16
00850014374655MARK3837-018XC837-018XC2025-10-16
D79690931MARK3909390932022-03-25
D79690901MARK390902017-04-14
D79690911MARK390912017-04-14
D79690921MARK390922017-04-14
D79641251MARK3412541252022-05-27
D79641261MARK3412641262022-05-27
D79653701MARK3537053702022-05-19
D79690031MARK390032025-03-06
D7969003MARK390032025-03-06
D79690011MARK390012025-02-28
D7969001MARK390012025-02-28
D7966125CS1MARK36125CS2021-04-22
D7966127CS1MARK36127CS2021-04-22
D7966129CS1MARK36129CS2021-04-23
D79661270MARK361272021-04-23
D79661290MARK361292021-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10609576330725Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576331098Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576331111Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576331418Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331432Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331449Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576331586Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576340007Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576360203Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576360210Puritan® HydraFlock®Puritan Medical ProductsKXF2026-07-20
10609576360241Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576360265Puritan® PurFlock Ultra®Puritan Medical ProductsKXF2026-07-20
10609576800068Puritan®Puritan Medical ProductsKXF2026-07-20
10609576800075Puritan®Puritan Medical ProductsKXF2026-07-20
10609576800297Puritan®Puritan Medical ProductsKXF2026-07-20
10609576800570Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800024Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800048Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800055Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800109Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800130Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800161Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800185Puritan® CalgiSwab®Puritan Medical ProductsKXF2026-07-20
30609576800208Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800406Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800543Puritan®Puritan Medical ProductsKXF2026-07-20
30609576800604Puritan®Puritan Medical ProductsKXF2026-07-20