FDA.reportPublic FDA data

KwikDose Oral Dispenser

Primary DI
00853832007231
Brand
KwikDose Oral Dispenser
Company
MEDSAFETY SOLUTIONS LLC
Model
8100
Catalog number
8100
Device description
0.5 mL Amber KwikDose Pharmacy Pack, 100 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
00853832007231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853832007231008538320072318538320072310853832007231

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 Volume0.5Milliliter

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
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
00853832007316KwikDose Oral Dispenser850185012024-12-31
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