FDA.reportPublic FDA data

Dover

Primary DI
30884521016709
Brand
Dover
Company
Cardinal Health, Inc.
Model
8887605189
Catalog number
8887605189
Device description
100% Silicone Foley Catheter,5 mL, 2-Way
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCMTray, catheterization, sterile urethral, with or without catheter (kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521016705PackageGS110In Commercial Distribution
30884521016709PackageGS16In Commercial Distribution
20884521016702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452101670510884521016705
3088452101670930884521016709
2088452101670220884521016702

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage catheterA sterile, flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge18French
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521015920Dover20512C20512C2016-09-24
10884521015982Dover20520C20520C2016-09-24
10884521016002Dover20522C20522C2016-10-13
10884521024991Kendall924092402018-06-27
10884521025004Kendall924292422018-06-27
10884521025011Kendall924392432018-06-27
10884521025028Kendall924492442018-06-27
20192253002062Curity21462146-2018-12-12
20884521143064Magellan888183351588818335152016-09-24
10884527007110Argyle888816305588881630552016-09-24
10885380173691Curity6309G6309G2019-11-14
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10884521141148Filac5040835040832016-09-24
10884521165045Kangaroo3881063881062016-09-24
10884521000674Dover35313531-2016-09-24
10884521001046Dover625562552016-09-24
10884521001138Dover825682562016-09-24
10884521001145Dover7016727016722016-09-24
10884521001206Dover7004ICLL7004ICLL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704945990RUSCHTELEFLEX INCORPORATEDFCM2026-05-12
10192253069549DoverCardinal Health 200, LLCFCM2026-01-20
10192253068535DoverCardinal Health 200, LLCFCM2026-01-16
10192253068542DoverCardinal Health 200, LLCFCM2026-01-16
10192253068559DoverCardinal Health 200, LLCFCM2026-01-16
10192253068566DoverCardinal Health 200, LLCFCM2026-01-16
10192253068573DoverCardinal Health 200, LLCFCM2026-01-16
10192253068580DoverCardinal Health 200, LLCFCM2026-01-16
10192253068597DoverCardinal Health 200, LLCFCM2026-01-16
10192253068610DoverCardinal Health 200, LLCFCM2026-01-16
10192253068665DoverCardinal Health 200, LLCFCM2026-01-16
10192253068702DoverCardinal Health 200, LLCFCM2026-01-16
10192253067958DoverCardinal Health 200, LLCFCM2026-01-15
10192253067996DoverCardinal Health 200, LLCFCM2026-01-15
10192253068009DoverCardinal Health 200, LLCFCM2026-01-15
10192253070859DoverCardinal Health 200, LLCFCM2026-01-15
10192253027754DoverCardinal Health 200, LLCFCM2025-12-10
10192253028836DoverCardinal Health 200, LLCFCM2025-12-10
10192253028843DoverCardinal Health 200, LLCFCM2025-12-10
10192253030174DoverCardinal Health 200, LLCFCM2025-10-17
10192253028935DoverCardinal Health 200, LLCFCM2025-09-16
10192253028942DoverCardinal Health 200, LLCFCM2025-09-16
10704411019541AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019558AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019565AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019572AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019589AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019596AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019602AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019619AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01