FDA.reportPublic FDA data

TruLock

Primary DI
00850058254364
Brand
TruLock
Company
HR PHARMACEUTICALS INC.
Model
TLFC5
Device description
TruLock™ Foley Securement Device, For 3-Way Foley,3-Way Swivel Clamp on Mesh Cloth Base, and Skin Prep Pad
Published
2025-03-03
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
EYJHOLDER, URETERAL CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYJHolder, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850058254361PackageGS125In Commercial Distribution
50850058254369PackageGS14In Commercial Distribution
00850058254364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005825436110850058254361
5085005825436950850058254369
00850058254364008500582543648500582543640850058254364

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, reusableA portable device designed to be worn or carried by a patient/layperson to hold a portable medical device (e.g., long-term recorder, wireless antenna, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, belt or strap intended to pass through the bag’s slots, headband, clothing, or trolley with wheels. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
828918164
Device count
1
Premarket exempt
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
00850067913238SteriGear®101362026-10-16
00850067913245SteriGear®101532026-10-16
00850067913252SteriGear®101542026-10-16
00850067913269SteriGear®102042026-10-16
00850067913276SteriGear®102242026-10-16
00850067913283SteriGear®102472026-10-16
00850067913054Fig Leaf®102732026-10-15
00850067913061Fig Leaf®102802026-10-15
00850067913078Fig Leaf®102862026-10-15
00850067913085SteriGear®101002026-10-15
00850067913092SteriGear®101012026-10-15
00850067913108SteriGear®101022026-10-15
00850067913115SteriGear®101072026-10-15
00850067913122SteriGear®101082026-10-15
00850067913139SteriGear®101092026-10-15
00850067913146SteriGear®101102026-10-15
00850067913153SteriGear®101112026-10-15
00850067913160SteriGear®101122026-10-15
00850067913177SteriGear®101192026-10-15
00850067913184SteriGear®101252026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874957346Create BiotechCREATE BIOTECH CO., LTD.EYJ2026-07-21
10197344157174MEDLINEMEDLINE INDUSTRIES, INC.EYJ2026-07-17
10197344111527MEDLINEMEDLINE INDUSTRIES, INC.EYJ2026-06-25
10197344111534MEDLINEMEDLINE INDUSTRIES, INC.EYJ2026-06-25
10192253071054MC JohnsonCardinal Health 200, LLCEYJ2026-05-20
10192253071153MC JohnsonCardinal Health 200, LLCEYJ2026-05-20
10885380211256MC JohnsonCardinal Health 200, LLCEYJ2026-05-20
00850067913009TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
00850067913016TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
10850067913006TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
10850067913013TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
00612479280687McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281189McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281202McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281226McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281196McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479280717McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281219McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281233McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
05430004283522FlexGRIPBedalEYJ2025-12-03
05430004283782FlexGRIPBedalEYJ2025-12-03
05430004283539FlexGRIPBedalEYJ2025-12-03
05430004283799FlexGRIPBedalEYJ2025-12-03
05430003674284FlexGRIPBedalEYJ2025-12-01
05430003674291FlexGRIPBedalEYJ2025-12-01
06009900639604Another HandWISMED PL SP Z O OEYJ2025-03-17
00850058254333TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
00850058254371TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10850058254330TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10850058254361TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03