FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756767908
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
54-8142R
Device description
Enteral Safe Feeding Tube
Published
2017-04-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPDTUBE, FEEDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPDTube, FeedingGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756767908PackageGS1100In Commercial Distribution
00749756767903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975676790850749756767908
00749756767903007497567679037497567679030749756767903

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding kit, adult/paediatric, sterileA collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. 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
false
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
08015262035662NUTRIFITPENTAFERTE ITALIA SRLFPD2025-07-03
53660812094530VYGONVYGONFPD2025-03-31
33660812106628VYGONVYGONFPD2025-03-31
33660812114845VYGONVYGONFPD2025-03-31
53660812118915VYGONVYGONFPD2025-03-31
53660812118922VYGONVYGONFPD2025-03-31
53660812118946VYGONVYGONFPD2025-03-31
33660812118959VYGONVYGONFPD2025-03-31
53660812126392VYGONVYGONFPD2025-03-31
33660812126404VYGONVYGONFPD2025-03-31
53660812145324VYGONVYGONFPD2025-03-31
33660812145924VYGONVYGONFPD2025-03-31
53660812145935VYGONVYGONFPD2025-03-31
33660812147089VYGONVYGONFPD2025-03-31
53660812154227VYGONVYGONFPD2025-03-31
53660812145317VYGONVYGONFPD2025-03-20
53660812166541VYGONVYGONFPD2025-03-20
33660812064881VYGONVYGONFPD2025-03-15
33660812073388VYGONVYGONFPD2025-03-15
53660812073450VYGONVYGONFPD2025-03-15
33660812085473VYGONVYGONFPD2025-03-15
33660812102941VYGONVYGONFPD2025-03-15
53660812109036VYGONVYGONFPD2025-03-15
33660812109063VYGONVYGONFPD2025-03-15
33660812132290VYGONVYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KGFPD2025-03-15
33660812132306VYGONVYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KGFPD2025-03-15
53660812133079VYGONVYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KGFPD2025-03-15
53660812134229VYGONVYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KGFPD2025-03-15
53660812149292VYGONVYGONFPD2025-02-17
53660812094370VYGONVYGONFPD2025-02-15