FDA.reportPublic FDA data

Dover

Primary DI
30884521017003
Brand
Dover
Company
Cardinal Health, Inc.
Model
8408
Catalog number
8408
Device description
Red Rubber Urethral Catheter
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K881667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K881667000KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATHThe Kendal Co.1988-08-12GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521017009PackageGS112In Commercial Distribution
30884521017003PackageGS1120In Commercial Distribution
20884521017006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452101700910884521017009
3088452101700330884521017003
2088452101700620884521017006

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral drainage catheter, reusableA flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]. The device may be male or female dedicated. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This side up;

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
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24
20884527000132Argyle888825738688882573862016-09-24
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704922649RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922656RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922663RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922670RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922687RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922694RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922700RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922717RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922724RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922731RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922748RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945433RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945440RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945457RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945464RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945471RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945488RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945495RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945501RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945518RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945815RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945822RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945839RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945853RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945860RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945877RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945884RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945891RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945907RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945914RUSCHTELEFLEX INCORPORATEDGBM2026-07-28