FDA.reportPublic FDA data

TruCath

Primary DI
00851809002715
Brand
TruCath
Company
HR PHARMACEUTICALS INC.
Model
HRIK002
Catalog number
HRIK002
Device description
TruCath Intermittent Catheter Insertion Kit
Published
2020-02-20
Public version status
Update
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
50851809002710PackageGS1100In Commercial Distribution
00851809002715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085180900271050851809002710
00851809002715008518090027158518090027150851809002715

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricantA substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

Contacts#

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

Regulatory Flags#

DUNS number
828918164
Device count
1
Premarket exempt
true
Kit
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
00851809002012HR Lubricating Jelly2012012018-08-27
00851809002036HR Lubricating Jelly2032032018-08-29
00851809002432Surgilube2810205122810205122018-08-27
00851809002456Surgilube2810205372810205372018-08-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459678653MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678660MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678677MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678684MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678691MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459679025MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
00850067913023TruCath®HR PHARMACEUTICALS INC.OHR2026-07-23
10197106910979CARDINAL HEALTHCardinal Health 200, LLCOHR2025-04-23
10197106963685CARDINAL HEALTHCardinal Health 200, LLCOHR2025-03-14
00610075096541VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096602VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096619VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096626VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096633VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075095667VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095674VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095681VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095698VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095704VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
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
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
10195327476946Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-08-13