FDA.reportPublic FDA data

KwikDose Oral Dispenser

Primary DI
00853832007316
Brand
KwikDose Oral Dispenser
Company
MEDSAFETY SOLUTIONS LLC
Model
8501
Catalog number
8501
Device description
1 mL Amber KwikDose Pharmacy Pack, 500 count
Published
2024-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853832007316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853832007316008538320073168538320073160853832007316

GMDN Terms#

Term, Definition table
TermDefinition
Non-ISO80369-3-standardized oral syringeA manual device consisting of a calibrated hollow barrel (cylinder) and a moveable plunger intended for the administration of oral medication. The tip is not formatted according to the standard for small-bore connectors for enteral applications (ISO 80369-3) [I.e., not ENFit], however the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080521478
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853832007125KwikDose Oral Dispenser710071002024-12-31
00853832007132KwikDose Oral Dispenser710171012024-12-31
00853832007149KwikDose Oral Dispenser710371032024-12-31
00853832007156KwikDose Oral Dispenser710571052024-12-31
00853832007163KwikDose Oral Dispenser711071102024-12-31
00853832007170KwikDose Oral Dispenser712071202024-12-31
00853832007187KwikDose Oral Dispenser750075002024-12-31
00853832007194KwikDose Oral Dispenser750175012024-12-31
00853832007200KwikDose Oral Dispenser750375032024-12-31
00853832007217KwikDose Oral Dispenser750575052024-12-31
00853832007224KwikDose Oral Dispenser751075102024-12-31
00853832007231KwikDose Oral Dispenser810081002024-12-31
00853832007248KwikDose Oral Dispenser810181012024-12-31
00853832007255KwikDose Oral Dispenser810381032024-12-31
00853832007262KwikDose Oral Dispenser810581052024-12-31
00853832007279KwikDose Oral Dispenser811081102024-12-31
00853832007286KwikDose Oral Dispenser812081202024-12-31
00853832007309KwikDose Oral Dispenser850085002024-12-31
00853832007323KwikDose Oral Dispenser850385032024-12-31
00853832007330KwikDose Oral Dispenser850585052024-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813360023643UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023674UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023681UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023640UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023657UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023671UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023688UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023647UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023678UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023685UnoDoseCordica Medical, Inc.KYX2026-10-20
40813360023644UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023667UnoDoseCordica Medical, Inc.KYX2026-10-06
20813360023664UnoDoseCordica Medical, Inc.KYX2026-10-06
30813360023661UnoDoseCordica Medical, Inc.KYX2026-10-06
MHC18140012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
09420060205039haakaaTHINK GREEN LIMITEDKYX2026-09-20
09420060205046haakaaTHINK GREEN LIMITEDKYX2026-09-20