FDA.reportPublic FDA data

AfterSwim

Primary DI
00859911004009
Brand
AfterSwim
Company
Bionix, LLC
Model
530
Catalog number
530
Device description
AfterSwim Water Removal
Published
2023-07-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
00859911004009PrimaryGS10
20859911004003Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859911004009008599110040098599110040090859911004009
2085991100400320859911004003

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal drying spongeA hand-held absorbent wedge intended to be partially inserted into the external auditory canal of the ear to dry the canal by absorbing water accumulated from bathing, showering, swimming, or diving, typically to prevent canal inflammation associated with water exposure (otitis externa or Swimmer’s ear). It is made of a soft spongy material and typically has a flared design to prevent over insertion and eardrum damage. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)551-7096Bionix@bionix.com

Regulatory Flags#

DUNS number
117844489
Device count
20
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859911004498Safe Ear Curette™ Variety Kit577757772021-12-10
00859911004429Green MicroLoop®122212222021-12-10
00859911004436Orange ControLoop®299929992021-12-10
00859911004443Red AngleLoop®344434442021-12-10
00859911004450Purple VersaLoop®411141112021-12-10
00859911004467Blue InfantScoop®488848882021-12-10
00859911004474Yellow CeraSpoon®633363332021-12-10
00859911004481White FlexLoop®955595552021-12-10
00859911004528Lighted AngleLoop®221022102021-12-10
00859911004535Lighted MicroLoop®222022202021-12-10
00859911004542Lighted WaveCurette™223022302021-12-10
00859911004559Lighted FlexLoop®224022402021-12-10
00859911004566Lighted Ear Curette™ Variety Pack224522452021-12-10
00859911004573Lighted CeraSpoon®225022502021-12-10
00859911004580Lighted InfantScoop®226022602021-12-10
00859911004597Lighted VersaLoop®227022702021-12-10
00859911004603Lighted CeraPik™228022802021-12-10
00859911004702Lighted Forceps for Foreign Body Removal275027502021-12-10
00859911004726Lighted Placement Tool285028502022-08-08
00714646000675Ear Wax Removal Kit7027022024-07-11

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