DeRoyal

Primary DI
50749756045754
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
81-080418
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
Rx
false
OTC
false
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
30749756045750PackageGS125In Commercial Distribution
50749756045754PackageGS150In Commercial Distribution
00749756045759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975604575030749756045750
5074975604575450749756045754
00749756045759007497560457597497560457590749756045759

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.

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
50749756399277DeRoyalDEROYAL INDUSTRIES, INC.EYC2025-07-23
50749756399284DeRoyalDEROYAL INDUSTRIES, INC.EYC2025-07-23
50749756399291DeRoyalDEROYAL INDUSTRIES, INC.EYC2025-07-23
50749756983995DeRoyalDEROYAL INDUSTRIES, INC.EYC2021-05-07
50749756984008DeRoyalDEROYAL INDUSTRIES, INC.EYC2021-05-07
50749756984015DeRoyalDEROYAL INDUSTRIES, INC.EYC2021-05-07
70885403251315N/ACarefusion Finland 320 OyEYC2016-09-14
70885403251322N/ACarefusion Finland 320 OyEYC2016-09-14
70885403251650N/ACarefusion Finland 320 OyEYC2016-09-14
30749756045743DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
30749756045767DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
30749756045774DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
30749756045781DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
30749756045798DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
30749756045804DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
50749756140114DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
50749756140121DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
50749756140138DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
50749756596652DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
30749756596665DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
50749756596676DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
50749756712267DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
30749756712270DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
50749756712281DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
30749756712294DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
30749756712300DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
50749756712311DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12
50749756824533DeRoyalDEROYAL INDUSTRIES, INC.EYC2016-09-12