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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883720EquateWAL-MART STORES, INC.KGX2026-07-31
06980297490019HuixiangJiangsu Huixiang Intelligent Technology Co., LtdKGX2026-07-31
20618125192339AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192384AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192391AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
04719874957346Create BiotechCREATE BIOTECH CO., LTD.EYJ2026-07-21
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17
10197344157174MEDLINEMEDLINE INDUSTRIES, INC.EYJ2026-07-17
B14350202030IDcheck SensorBeacon Biosignals, Inc.KGX2026-07-17
00850088144598CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-10
00850088144093CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-01
10197344111527MEDLINEMEDLINE INDUSTRIES, INC.EYJ2026-06-25
10197344111534MEDLINEMEDLINE INDUSTRIES, INC.EYJ2026-06-25
14931921902902BLUPRO Attachment TapeNIHON KOHDEN CORPORATIONKGX2026-06-23
00850087488556CeeportCEEPORT INC.KGX2026-06-12
16973405130119AODEJIANWenzhou Anqi Medical Supplies Co., LtdKGX2026-06-10
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09