FDA.reportPublic FDA data

Medline

Primary DI
40889942820215
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
UROT1041
Catalog number
UROT1041
Device description
TRAY CAUTI TEMP SENS 16FR 10ML
Published
2021-03-17
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
OHRCatheter care tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40889942820215PackageGS110In Commercial Distribution
10889942820214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088994282021540889942820215
1088994282021410889942820214

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10854913006201Intravesical Administration Kit UROGEN PHARMA LTDOHR2026-03-15
50850058254680TruAdvance™HR PHARMACEUTICALS INC.OHR2026-03-06
50850045818468TruAdvance®HR PHARMACEUTICALS INC.OHR2025-12-22
50850045818475TruAdvance®HR PHARMACEUTICALS INC.OHR2025-12-22
50850045818482TruAdvance®HR PHARMACEUTICALS INC.OHR2025-12-22
00850063139366Neil Medical Group Neil Medical GroupOHR2025-12-08
00850063139373Neil Medical Group Neil Medical GroupOHR2025-12-08
00850063139380Neil Medical Group Neil Medical GroupOHR2025-12-08
00850063139397Neil Medical Group Neil Medical GroupOHR2025-12-08
50198956214567CARDINAL HEALTHCardinal Health 200, LLCOHR2025-11-28
50850058254888TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254895TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254901TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254918TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254925TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254932TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254949TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254956TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254963TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50198956094374CARDINAL HEALTHCardinal Health 200, LLCOHR2025-08-25
50850058254765TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-11
50850058254970TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-11
50850058254987TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-11
50850058254857TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-05
50850058254864TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-05
50850058254871TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-05
50850058254826TruAdvanceHR PHARMACEUTICALS INC.OHR2025-07-25
50850058254833TruAdvanceHR PHARMACEUTICALS INC.OHR2025-07-25
50850058254840TruAdvanceHR PHARMACEUTICALS INC.OHR2025-07-25
10854913006171Intravesical Administration KitUROGEN PHARMA LTDOHR2025-06-16