FDA.report

DeRoyal

Primary DI
50749756767809
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
54-3665R
Device description
Enteral Safe Feeding Tube
Published
2016-09-12
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

Related Records

Contact Domains

Product Codes

CodeName
FPDTUBE, FEEDING

Product Code Classifications

CodeDeviceSpecialtyClass
FPDTube, FeedingGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50749756767809PackageGS110In Commercial Distribution
00749756767804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975676780950749756767809
00749756767804007497567678047497567678040749756767804

GMDN Terms

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

Contacts

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 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 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