FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380100299
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
AFA
Catalog number
AFA
Device description
Cardinal Health; Adhesive Foley Catheter Anchoring Device; Adhesive Anchor with Velcro Locking Mechanism
Published
2019-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
20885380100298PackageGS150In Commercial Distribution
50885380100299PackageGS110In Commercial Distribution
10885380100291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538010029820885380100298
5088538010029950885380100299
1088538010029110885380100291

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

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

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
00850058254364TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
00850058254371TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10850058254330TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03