FDA.reportPublic FDA data

Dover

Primary DI
30884521001668
Brand
Dover
Company
Cardinal Health, Inc.
Model
2540
Catalog number
2540
Device description
Vinyl Catheter Kit with Lubricating Jelly
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
GBMCATHETER, URETHRAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884521001668PackageGS1100In Commercial Distribution
10884521001664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088452100166830884521001668
1088452100166410884521001664

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kitA collection of sterile devices that includes an indwelling urethral catheter (commonly known as a Foley catheter), gloves, lubricating gel, and other related accessories intended for the drainage of urine from the bladder. The catheter has an inflatable balloon at the distal tip for retention in the urinary bladder after its insertion through the urethra, where it usually functions as an indwelling therapeutic device for urinary incontinence or as a means to void for non-ambulatory patients. The catheter will be applied by trained staff and may or may not be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

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
false
HCT/P
false
Kit
true
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
10884521015791Dover888762312588876231252016-09-24
10884521153219Monoject118606026511860602652016-09-24
10884527021932Uni-PatchEP84580EP845802016-09-24
20884521012216Monoject888153578888815357882016-09-24
20884521012254Monoject888156018288815601822016-09-24
20884521014159Monoject888151613588815161352016-10-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704943019TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943026TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943033TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943040TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943057TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943125TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943132TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943149TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943170TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943194TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943255TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
10192253058437DoverCardinal Health 200, LLCGBM2025-01-23
10192253058444DoverCardinal Health 200, LLCGBM2025-01-23
10192253058451DoverCardinal Health 200, LLCGBM2025-01-23
10192253058468DoverCardinal Health 200, LLCGBM2025-01-23
10192253058475DoverCardinal Health 200, LLCGBM2025-01-23
10192253058482DoverCardinal Health 200, LLCGBM2025-01-23
10192253058499DoverCardinal Health 200, LLCGBM2025-01-23
10192253058505DoverCardinal Health 200, LLCGBM2025-01-23
10192253058512DoverCardinal Health 200, LLCGBM2025-01-23
10192253058529DoverCardinal Health 200, LLCGBM2025-01-23
10192253058536DoverCardinal Health 200, LLCGBM2025-01-23
10192253058543DoverCardinal Health 200, LLCGBM2025-01-23
10192253027761DoverCardinal Health 200, LLCGBM2022-11-08
15390166167122VaPro PocketHOLLISTER INCORPORATEDGBM2022-11-01
15390166167139VaPro PocketHOLLISTER INCORPORATEDGBM2022-11-01
15390166167146VaPro PocketHOLLISTER INCORPORATEDGBM2022-11-01
15390166167153VaPro PocketHOLLISTER INCORPORATEDGBM2022-11-01
00610075052967VaPro PocketHOLLISTER INCORPORATEDGBM2022-09-30
00610075052974VaPro PocketHOLLISTER INCORPORATEDGBM2022-09-30