FDA.reportPublic FDA data

MALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 18CH

Primary DI
05055788710509
Brand
MALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 18CH
Company
FLEXICARE MEDICAL LIMITED
Model
03-52018U
Published
2016-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KODCatheter, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132619000CLASSIC INTERMITTENT CATHETERFlexicare Medical, Ltd.2013-10-11EZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055788710509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788710509050557887105095055788710509

GMDN Terms#

Term, Definition table
TermDefinition
Urine-sampling urethral catheterA sterile flexible tube inserted into the bladder, via the urethra, to obtain a sample of urine that has not been contaminated by urethral passage. The distal end can have various tip designs, and the proximal end may terminate in a soft connecting piece to connect to a urine specimen collection container. The device is applied by a healthcare provider to the patient, is typically made of polyvinyl chloride (PVC), and may or may not be coated with a lubricating substance. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
504406273
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055788767640Leg Bag Holder Extra Large00-0038U2020-03-25
05055788767671Leg Bag Holder Large00-0037U2020-03-25
05055788767701Leg Bag Holder Medium00-0036U2020-03-25
05055788767732Leg Bag Holder Small00-0035U2020-03-25
05055788787044Flexicare040-11-0000U2026-03-31
05055788787068Flexicare040-12-0130U2026-03-31
05055788787082Flexicare040-12-0140U2026-03-31
05055788787105Flexicare040-12-2130U2026-03-31
05055788787129Flexicare040-12-2135U2026-03-31
05055788787143Flexicare040-12-2140U2026-03-31
05055788791317Flexicare030-620/1U2024-03-13
05055931101963Maxineb Duo Filter Pad032-10-021U2020-03-27
05055931101970Maxineb Duo032-10-031U2020-03-27
05055931101994Maxineb Duo Nebulizer + Mouthpiece032-10-033U2020-03-27
05055931102014Maxineb Duo Nebulizer + Mouthpiece And Filter032-10-034U2020-03-27
05055931102038Maxineb Duo Filter032-10-035U2020-03-27
05055931102052Maxineb Duo Filter Master Case032-10-036U2020-03-27
05055931102076Maxineb Duo Nebulizer And Tubing032-10-037U2020-03-27
05055931102090Maxineb Duo Nebulizer + Mouthpiece And Tubing032-10-038U2020-03-27
05055931102113Maxineb Duo Nebulizer + Mouthpiece, Tubing And Filter032-10-039U2020-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253024258DoverCardinal Health 200, LLCKOD2026-03-20
10192253024265DoverCardinal Health 200, LLCKOD2026-03-20
10192253024272DoverCardinal Health 200, LLCKOD2026-03-20
10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
10192253029079DoverCardinal Health 200, LLCKOD2025-04-07
10192253029086DoverCardinal Health 200, LLCKOD2025-04-07
10192253029093DoverCardinal Health 200, LLCKOD2025-04-07
10192253029109DoverCardinal Health 200, LLCKOD2025-04-07
10192253029116DoverCardinal Health 200, LLCKOD2025-04-07
10192253029123DoverCardinal Health 200, LLCKOD2025-04-07
10192253030310DoverCardinal Health 200, LLCKOD2025-04-07
10192253030327DoverCardinal Health 200, LLCKOD2025-04-07
10192253030334DoverCardinal Health 200, LLCKOD2025-04-07
10192253030341DoverCardinal Health 200, LLCKOD2025-04-07
10192253030358DoverCardinal Health 200, LLCKOD2025-04-07
10192253030365DoverCardinal Health 200, LLCKOD2025-04-07
10192253030648DoverCardinal Health 200, LLCKOD2025-01-15
10192253031041DoverCardinal Health 200, LLCKOD2025-01-15
10192253031423DoverCardinal Health 200, LLCKOD2025-01-15
10192253030624DoverCardinal Health 200, LLCKOD2025-01-14
10192253031409DoverCardinal Health 200, LLCKOD2025-01-14
10192253031416DoverCardinal Health 200, LLCKOD2025-01-14
10192253038897DoverCardinal Health 200, LLCKOD2025-01-14
10192253066203DoverCardinal Health 200, LLCKOD2024-09-04
10192253066210DoverCardinal Health 200, LLCKOD2024-09-04
10192253066227DoverCardinal Health 200, LLCKOD2024-09-04
10192253066234DoverCardinal Health 200, LLCKOD2024-09-04
10192253066241DoverCardinal Health 200, LLCKOD2024-09-04
10192253066258DoverCardinal Health 200, LLCKOD2024-09-04
10192253066265DoverCardinal Health 200, LLCKOD2024-09-04