FDA.reportPublic FDA data

TruCath

Primary DI
00850058254432
Brand
TruCath
Company
HR PHARMACEUTICALS INC.
Model
D10022
Device description
TruCath® Duo™ Dual Balloon Catheter
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
EZLCATHETER, RETENTION TYPE, BALLOON

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850058254439PackageGS110In Commercial Distribution
50850058254437PackageGS150In Commercial Distribution
00850058254432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005825443910850058254439
5085005825443750850058254437
00850058254432008500582544328500582544320850058254432

GMDN Terms#

Term, Definition table
TermDefinition
Device-irrigation sterile waterA fluid consisting of sterile water (H2O) that is used exclusively for the cleaning and irrigation of a device (e.g., a Foley catheter or a tracheobronchial suction catheter). It is not intended for wound irrigation or injection or intravenous (IV) administration. The device is usually available in a plastic container or bottle of various sizes. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 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
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
10192253031782DoverCardinal Health 200, LLCEZL2026-06-18
08886483507470Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507494Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
10192253068221DoverCardinal Health 200, LLCEZL2026-01-15
10192253068238DoverCardinal Health 200, LLCEZL2026-01-15
10192253067651DoverCardinal Health 200, LLCEZL2025-04-14
10192253067668DoverCardinal Health 200, LLCEZL2025-04-14
10192253067675DoverCardinal Health 200, LLCEZL2025-04-14
10192253067682DoverCardinal Health 200, LLCEZL2025-04-14
10192253031423DoverCardinal Health 200, LLCEZL2025-01-15
10192253031409DoverCardinal Health 200, LLCEZL2025-01-14
10192253031416DoverCardinal Health 200, LLCEZL2025-01-14
10192253038897DoverCardinal Health 200, LLCEZL2025-01-14
10192253031140DoverCardinal Health 200, LLCEZL2024-12-20
10192253031164DoverCardinal Health 200, LLCEZL2024-12-20
10192253066203DoverCardinal Health 200, LLCEZL2024-09-04
10192253066210DoverCardinal Health 200, LLCEZL2024-09-04
10192253066227DoverCardinal Health 200, LLCEZL2024-09-04
10192253066234DoverCardinal Health 200, LLCEZL2024-09-04
10192253066241DoverCardinal Health 200, LLCEZL2024-09-04
10192253066258DoverCardinal Health 200, LLCEZL2024-09-04
10192253066265DoverCardinal Health 200, LLCEZL2024-09-04
10192253066272DoverCardinal Health 200, LLCEZL2024-09-04
10192253066289DoverCardinal Health 200, LLCEZL2024-09-04
10192253066296DoverCardinal Health 200, LLCEZL2024-09-04
10192253066302DoverCardinal Health 200, LLCEZL2024-09-04
10192253066319DoverCardinal Health 200, LLCEZL2024-09-04
10192253066326DoverCardinal Health 200, LLCEZL2024-09-04
10192253066333DoverCardinal Health 200, LLCEZL2024-09-04