FDA.reportPublic FDA data

TruCath

Primary DI
00850025153294
Brand
TruCath
Company
HR PHARMACEUTICALS INC.
Model
HC0810
Catalog number
HC0810
Device description
Pediatric Hydro Coude 8FR
Published
2023-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBMCATHETER, URETHRAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111405000BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,Hangzhou Bever Medical Devices Co., Ltd.2012-02-13GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850025153291PackageGS130In Commercial Distribution
50850025153299PackageGS110In Commercial Distribution
00850025153294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002515329110850025153291
5085002515329950850025153299
00850025153294008500251532948500251532940850025153294

GMDN Terms#

Term, Definition table
TermDefinition
Urine-sampling urethral catheterA sterile flexible tube inserted into the bladder, via the urethra, to obtain a sample of urine that has not been contaminated by urethral passage. The distal end can have various tip designs, and the proximal end may terminate in a soft connecting piece to connect to a urine specimen collection container. The device is applied by a healthcare provider to the patient, is typically made of polyvinyl chloride (PVC), and may or may not be coated with a lubricating substance. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(717)252-1110sbenser@hrpharma.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
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
00850045818685TruCath OasisRH1416S2024-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704943019TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943026TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943033TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943040TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943057TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943125TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943132TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943149TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943170TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943194TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943255TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
10192253058437DoverCardinal Health 200, LLCGBM2025-01-23
10192253058444DoverCardinal Health 200, LLCGBM2025-01-23
10192253058451DoverCardinal Health 200, LLCGBM2025-01-23
10192253058468DoverCardinal Health 200, LLCGBM2025-01-23
10192253058475DoverCardinal Health 200, LLCGBM2025-01-23
10192253058482DoverCardinal Health 200, LLCGBM2025-01-23
10192253058499DoverCardinal Health 200, LLCGBM2025-01-23
10192253058505DoverCardinal Health 200, LLCGBM2025-01-23
10192253058512DoverCardinal Health 200, LLCGBM2025-01-23
10192253058529DoverCardinal Health 200, LLCGBM2025-01-23
10192253058536DoverCardinal Health 200, LLCGBM2025-01-23
10192253058543DoverCardinal Health 200, LLCGBM2025-01-23
00610075094394VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094400VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094424VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094431VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094448VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094462VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
10192253027761DoverCardinal Health 200, LLCGBM2022-11-08