FDA.reportPublic FDA data

SafeStraw™ NeoTarget Co-brand

Primary DI
00714646000057
Brand
SafeStraw™ NeoTarget Co-brand
Company
Bionix, LLC
Model
203
Catalog number
203
Device description
SafeStraw, White, NeoTarget Co-brand
Published
2022-01-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILCUTENSIL, EATING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILCUtensil, EatingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714646000057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714646000057007146460000577146460000570714646000057

GMDN Terms#

Term, Definition table
TermDefinition
Assistive drinking strawA tubular device designed to be used by a person with a disability to suck fluids or liquefied food from a container and into their mouth. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117844489
Device count
1
DM exempt
true
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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Primary DI, Brand, Company table
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00810226440111ViveVIVE HEALTH LLCILC2026-06-04
00661392008076LSL HEALTHCARELSL Industries, LLCILC2025-05-15
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00057475541019BIOS LivingThermor LtdILC2024-03-21
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00023601035073CarexDrive Devilbiss HealthcareILC2023-12-07
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00194346098057EQUATEDrive Devilbiss HealthcareILC2023-08-04
30194346098058EQUATECOMPASS HEALTH BRANDS CORP.ILC2023-08-04
00859911004825SafeStrawBionix, LLCILC2023-07-19
00859911004832SafeStrawBionix, LLCILC2023-07-19
10859911004822SafeStrawBionix, LLCILC2023-07-19
10859911004839SafeStrawBionix, LLCILC2023-07-19
10686864048777SOLONAMD Medicom IncILC2023-07-10
10686864048821AMD-RITMED SOLONAMD Medicom IncILC2023-07-10
20686864048774SOLONAMD Medicom IncILC2023-07-10
20686864048828AMD-RITMED SOLONAMD Medicom IncILC2023-07-10
07320450002021Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002038Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002045Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002052Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002076Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002083Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002090Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002106Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002113Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002120Etac Supply Center ABEtac Supply Center ABILC2022-12-07