FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756767922
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
54-5030
Catalog number
54-5030
Device description
Enteral Safe Feeding Syringe
Published
2021-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
50749756767922PackageGS1100In Commercial Distribution
00749756767927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975676792250749756767922
00749756767927007497567679277497567679270749756767927

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813360023639DoselogixTEAM TECHNOLOGIES, INC.KYX2026-03-24
80827989007853Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007846Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007860Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007877Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007884Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
80827989007891Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
00810126506351Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506368Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506375Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506382Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506399Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506405Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506412Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506429Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506436Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506443Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00810126506450Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKYX2025-12-16
00194346098088EquateWAL-MART STORES, INC.KYX2025-11-14
04046955861132Exadoral®B. BRAUN MEDICAL INC.KYX2025-09-08
04046955861170Exadoral®B. BRAUN MEDICAL INC.KYX2025-09-08
04046955861217Exadoral®B. BRAUN MEDICAL INC.KYX2025-09-08
10810080612492OptiDropper®, SafeFill™MPS Pharma & Medical, Inc.KYX2025-08-19
10810080612485OptiDropper®MPS Pharma & Medical, Inc.KYX2025-08-15
00813360023189DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
00813360023196DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
00813360023202DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
00813360023219DoselogixTEAM TECHNOLOGIES, INC.KYX2025-08-01
10810080612461OptiDropper®MPS Pharma & Medical, Inc.KYX2025-07-19
00813360023240DoselogixTEAM TECHNOLOGIES, INC.KYX2025-06-05