FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756578986
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
71-C501
Catalog number
71-C501
Device description
Tubing Suction Connector
Published
2021-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756578986PackageGS1100In Commercial Distribution
00749756578981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975657898650749756578986
00749756578981007497565789817497565789810749756578981

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). 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
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150028399Liberant™EV3, INCBYY2026-05-07
00628725002224MED-RXCanadian Hospital Specialties LimitedBYY2025-04-25
00628725002231MED-RXCanadian Hospital Specialties LimitedBYY2025-04-25
10192253042894ArgyleCardinal Health 200, LLCBYY2025-02-27
10192253003222ArgyleCardinal Health 200, LLCBYY2024-09-27
50885380194519CARDINAL HEALTHCardinal Health 200, LLCBYY2024-09-18
14026704919410PILLINGTELEFLEX INCORPORATEDBYY2024-07-15
14026704919427PILLINGTELEFLEX INCORPORATEDBYY2024-07-15
14026704919434PILLINGTELEFLEX INCORPORATEDBYY2024-07-15
10840330704264ProCureTwin Med, LLCBYY2024-03-25
10840330704271ProCureTwin Med, LLCBYY2024-03-25
10840330704288ProCureTwin Med, LLCBYY2024-03-25
10840330704295ProCureTwin Med, LLCBYY2024-03-25
10840330704301ProCureTwin Med, LLCBYY2024-03-25
10840330704318ProCureTwin Med, LLCBYY2024-03-25
10840330704325ProCureTwin Med, LLCBYY2024-03-25
10840330704332ProCureTwin Med, LLCBYY2024-03-25
10840330704349ProCureTwin Med, LLCBYY2024-03-25
10850049784891SURGYCOSurgyco LLCBYY2023-10-31
10850049784907SURGYCOSurgyco LLCBYY2023-10-31
10653160360612MEDLINEMEDLINE INDUSTRIES, INC.BYY2023-05-29
B090ASP10390Control 10T Mechanical Thrombectomy FilterZIEN MEDICAL TECHNOLOGIES, INC.BYY2023-03-28
B090ASP10400Control 10T Mechanical Thrombectomy System Tubing, Female SuctionZIEN MEDICAL TECHNOLOGIES, INC.BYY2023-03-28
00749756376747DeRoyalDEROYAL INDUSTRIES, INC.BYY2023-02-02
00385640061629SUMMIT MEDICALSummit Medical, Inc.BYY2022-12-19
B090MT100Control 10T Mechanical Thrombectomy FilterZIEN MEDICAL TECHNOLOGIES, INC.BYY2022-10-24
B090MT1010030Control 10T Mechanical Thrombectomy System Tubing, 3-PackZIEN MEDICAL TECHNOLOGIES, INC.BYY2022-10-24
B090MT10100F0Control 10T Mechanical Thrombectomy System Tubing, Female SuctionZIEN MEDICAL TECHNOLOGIES, INC.BYY2022-10-24
20653405015106CONMEDConmed CorporationBYY2022-06-06
10080196035199MedlineMEDLINE INDUSTRIES, INC.BYY2022-04-15