DeRoyal

Primary DI
00749756045780
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
81-080412
Device description
Foley Catheter with Temperature Sensor
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYCCATHETER, UPPER URINARY TRACT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYCCatheter, Upper Urinary TractGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30749756045781PackageGS125In Commercial Distribution
50749756045785PackageGS150In Commercial Distribution
00749756045780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975604578130749756045781
5074975604578550749756045785
00749756045780007497560457807497560457800749756045780

GMDN Terms#

Term, Definition table
TermDefinition
Temperature-monitoring indwelling urethral drainage catheterA sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as a long-term indwelling device for continuous urinary drainage and simultaneous monitoring of core body temperature through its integral temperature sensor, typically during or after surgery or in the presence of obstruction or paralysis. It may have a bent tip (coude) for negotiation of the prostatic curve and is typically made of silicone. It is inserted by trained staff and commonly known as a Foley catheter. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
00749756399272DeRoyalDEROYAL INDUSTRIES, INC.EYC2025-07-23
00749756399289DeRoyalDEROYAL INDUSTRIES, INC.EYC2025-07-23
00749756399296DeRoyalDEROYAL INDUSTRIES, INC.EYC2025-07-23
50749756399277DeRoyalDEROYAL INDUSTRIES, INC.EYC2025-07-23
50749756399284DeRoyalDEROYAL INDUSTRIES, INC.EYC2025-07-23
50749756399291DeRoyalDEROYAL INDUSTRIES, INC.EYC2025-07-23
00749756983990DeRoyalDEROYAL INDUSTRIES, INC.EYC2021-05-07
00749756984003DeRoyalDEROYAL INDUSTRIES, INC.EYC2021-05-07
00749756984010DeRoyalDEROYAL INDUSTRIES, INC.EYC2021-05-07
50749756983995DeRoyalDEROYAL INDUSTRIES, INC.EYC2021-05-07
50749756984008DeRoyalDEROYAL INDUSTRIES, INC.EYC2021-05-07
50749756984015DeRoyalDEROYAL INDUSTRIES, INC.EYC2021-05-07
10885403251313N/ACarefusion Finland 320 OyEYC2016-09-14
10885403251320N/ACarefusion Finland 320 OyEYC2016-09-14
10885403251658N/ACarefusion Finland 320 OyEYC2016-09-14
70885403251315N/ACarefusion Finland 320 OyEYC2016-09-14
70885403251322N/ACarefusion Finland 320 OyEYC2016-09-14
70885403251650N/ACarefusion Finland 320 OyEYC2016-09-14
00749756045742DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
00749756045759DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
00749756045766DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
00749756045773DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
00749756045797DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
00749756045803DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
00749756140119DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
00749756140126DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
00749756140133DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
00749756596657DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
00749756596664DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
00749756596671DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12