FDA.reportPublic FDA data

SafeStraw™ Drinking Aid for Thin Liquid

Primary DI
10859911004082
Brand
SafeStraw™ Drinking Aid for Thin Liquid
Company
Bionix, LLC
Model
202
Catalog number
202
Device description
SafeStraw. White, Thin Liquid
Published
2022-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00859911004085PrimaryGS10
10859911004082Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859911004085008599110040858599110040850859911004085
1085991100408210859911004082

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
12
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00859911004184Bionix Development Corporation370037002017-01-28
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

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Primary DI, Brand, Company table
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30194346098058EQUATECOMPASS HEALTH BRANDS CORP.ILC2023-08-04
00859911004825SafeStrawBionix, LLCILC2023-07-19
00859911004832SafeStrawBionix, LLCILC2023-07-19
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10859911004839SafeStrawBionix, LLCILC2023-07-19
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10686864048821AMD-RITMED SOLONAMD Medicom IncILC2023-07-10
20686864048774SOLONAMD Medicom IncILC2023-07-10
20686864048828AMD-RITMED SOLONAMD Medicom IncILC2023-07-10
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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
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07320450002090Etac Supply Center ABEtac Supply Center ABILC2022-12-07
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07320450002120Etac Supply Center ABEtac Supply Center ABILC2022-12-07