FDA.reportPublic FDA data

Foley Loc

Primary DI
00850014574208
Brand
Foley Loc
Company
PEPPER MEDICAL INC.
Model
650
Catalog number
650
Device description
Multi Tube Holder
Published
2020-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYJHOLDER, URETERAL CATHETER
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYJHolder, Ureteral CatheterGastroenterology, Urology1
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850014574205PackageGS150In Commercial Distribution
00850014574208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001457420510850014574205
00850014574208008500145742088500145742080850014574208

GMDN Terms#

Term, Definition table
TermDefinition
Urinary catheter holderA device designed to be attached to a patient's body to hold an indwelling urinary catheter line (e.g., Foley) in place. It consists of a wrap or adhesive strip/pad placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook, loop, clip) without creating excessive pressure on it and permitting visual inspection of the site. It is not designed to hold a urine collection bag. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)647-0172gschuster@peppermedical.com

Regulatory Flags#

DUNS number
622637098
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014574185Foley Tie6066062020-04-17
00850014574192Tube Tie544554452020-04-17
10850014574014Pepper Medical Closed SuctionCS24-DS-14CS24-DS-142025-09-11
10850014574038Pepper Medical Closed SuctionCS24-T-14CS24-T-142025-09-11
10850014574052Pepper Medical Closed SuctionCS24-10-ETTCS24-10-ETT2025-09-11
00850014574659Pepper MedicalHME-712-Mini2025-11-07
00850014574406Trach Tie5025022020-04-17
00850014574413Trach Tie502P502P2020-04-17
00850014574154Trach Tie501W501W2020-04-17
00850014574215Trach Tie100110012020-04-17
10850014574878Pepper Medical Closed SuctionCS24-6CS24-62025-09-15
10850014574892Pepper Medical Closed SuctionCS24-8-ETTCS24-8-ETT2025-09-15
10850014574915Pepper Medical Closed SuctionCS24-T-12CS24-T-122025-09-15
10850014574922Pepper Medical Closed SuctionCS24-T-16CS24-T-162025-09-15
10850014574830Pepper Medical Closed SuctionCS24-12-ETTCS24-12-ETT2025-09-15
10850014574861Pepper Medical Closed SuctionCS24-6CS24-62025-09-15
10850014574885Pepper Medical Closed SuctionCS24-8-ETTCS24-8-ETT2025-09-15
10850014574908Pepper Medical Closed SuctionCS24-T-12CS24-T-122025-09-15
10850014575066Pepper Medical Closed SuctionCS24-T-16CS24-T-162025-09-15
10850014574854Pepper Medical Closed SuctionCS24-14CS24-142025-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428344095CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-16
20665973032423DukalDukal LLCKGX2026-10-14
20665973032430DukalDukal LLCKGX2026-10-14
00050428142677CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428143124CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340523CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340936CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428341308CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342053CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342121CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342602CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428346396CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428347133CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00389152744957Adhesive Sleeve, 10 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00389152745459Adhesive Sleeve, 2 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00197998029844Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-05
00311917088556WalgreensWALGREEN CO.KGX2026-09-30
08859922800036EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800043EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800050EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
00850087488877CeeportCEEPORT INC.KGX2026-09-29
00197998095641Transpore™Solventum US LLCKGX2026-09-25
00197998095672Transpore™Solventum US LLCKGX2026-09-25
00197998095702Transpore™Solventum US LLCKGX2026-09-25
00197998095733Transpore™Solventum US LLCKGX2026-09-25
00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25
00197998164118Transpore™Solventum US LLCKGX2026-09-25