FDA.reportPublic FDA data

TruCath

Primary DI
00850058254807
Brand
TruCath
Company
HR PHARMACEUTICALS INC.
Model
RTS14
Device description
TruCath™ Red Rubber Intermittent Catheter Tray
Published
2025-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50850058254802PackageGS120In Commercial Distribution
00850058254807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085005825480250850058254802
00850058254807008500582548078500582548070850058254807

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(717)252-1110sbenser@hrhealthcare.com

Regulatory Flags#

DUNS number
828918164
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850067913023TruCath®FP12026-07-23
00850045818494TruCath OasisRH08162023-06-23
00850045818500TruCath OasisRH10162023-06-23
00850045818517TruCath OasisRH12162023-06-23
00850045818524TruCath OasisRH14162023-06-23
00850045818531TruCath OasisRH16162023-06-23
00850045818548TruCath OasisRH18162023-06-23
00850045818555TruCath OasisRH1016C2023-06-23
00850045818562TruCath OasisRH1216C2023-06-23
00850045818579TruCath OasisRH1416C2023-06-23
00850045818586TruCath OasisRH1616C2023-06-23
00850045818593TruCath OasisRH08062023-06-23
00850045818609TruCath OasisRH10062023-06-23
00850045818616TruCath OasisRH12062023-06-23
00850045818623TruCath OasisRH14062023-06-23
00850045818630TruCath OasisRH16062023-06-23
00850045818647TruCath OasisRH08102023-06-23
00850045818654TruCath OasisRH10102023-06-23
00850045818661TruCath OasisRH1016S2024-03-21
00850045818678TruCath OasisRH1216S2024-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850067913023TruCath®HR PHARMACEUTICALS INC.OHR2026-07-23
10198956385054CARDINAL HEALTHCardinal Health 200, LLCOHR2026-04-27
10198956214569CARDINAL HEALTHCardinal Health 200, LLCOHR2025-11-28
10198956094376CARDINAL HEALTHCardinal Health 200, LLCOHR2025-08-25
10197106910979CARDINAL HEALTHCardinal Health 200, LLCOHR2025-04-23
10197344148981MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-07
10197344148998MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-02
10197344149001MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-02
10197106963685CARDINAL HEALTHCardinal Health 200, LLCOHR2025-03-14
10198459028793Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2024-07-29
10809160429389Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHR2024-07-10
10198459044588Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2024-06-23
10195327610999MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-25
10193489834482MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10193489939262MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10080196997084MedlineMEDLINE INDUSTRIES, INC.OHR2023-12-28
10195327468880Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-12-21
10653160995791Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-12-21
10850053289191SURGYCOSurgyco LLCOHR2023-12-15
10195327443023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10195327443108Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10197106420386CARDINAL HEALTHCardinal Health 200, LLCOHR2023-10-12
10195327512514Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-01
10195327503192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-09-17
10610075177063ApogeeHOLLISTER INCORPORATEDOHR2023-08-22
10195327476946Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-08-13
10195327245474Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-07-29
10653160995517Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-07-29
10195327195236MedlineMEDLINE INDUSTRIES, INC.OHR2023-06-08
10195327242862MedlineMEDLINE INDUSTRIES, INC.OHR2023-06-08