FDA.reportPublic FDA data

GENTLECATH GLIDE

Primary DI
00768455205356
Brand
GENTLECATH GLIDE
Company
CONVATEC, PURCHASING DEPARTMENT
Model
421568
Device description
GentleCath Glide Male CH16 (1x30pk)
Published
2022-11-03
Public version status
New
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
KODCATHETER, UROLOGICAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161344000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161344000GentleCath Glide Intermittent CatheterConvatec Limited2016-09-20KOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00768455202270PackageGS18In Commercial Distribution
00768455205356PackageGS130In Commercial Distribution
00768455205011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455202270007684552022707684552022700768455202270
00768455205356007684552053567684552053560768455205356
00768455205011007684552050117684552050110768455205011

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18004228811cic@convatec.com

Regulatory Flags#

DUNS number
809784593
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768455145836FLEXI-SEAL4217032019-11-18
00768455157150FLEXI-SEAL4223032019-11-18
00768455185924FLEXI-SEAL4111082022-09-09
00768455209620FLEXI-SEAL4238542023-08-16
30768455143017FLEXI-SEAL4216304216302017-04-26
00768455108565FLEXI-SEAL4111004111002016-09-01
00768455109852FLEXI-SEAL4111004111002016-09-01
00768455117178FLEXI-SEAL4180002016-09-01
00768455143016FLEXI-SEAL4216302017-05-12
00768455201303AVELLE4466504466502023-02-22
00768455108268STOMAHESIVE0255102022-09-28
00768455101399ACTIVELIFE0209222018-11-09
00768455101405ACTIVELIFE0227502018-11-09
00768455101412ACTIVELIFE0227512018-11-09
00768455101429ACTIVELIFE0227522018-11-09
00768455101436ACTIVELIFE0227532018-11-09
00768455101443ACTIVELIFE227542018-11-09
00768455101450ACTIVELIFE0227552018-11-09
00768455101467ACTIVELIFE0227562018-11-09
00768455101474ACTIVELIFE0227572018-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704926944RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704926951RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704926968RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704933843RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
10192253031782DoverCardinal Health 200, LLCKOD2026-06-18
00610075097432OnliHOLLISTER INCORPORATEDGBM2026-02-01
00610075097449OnliHOLLISTER INCORPORATEDGBM2026-02-01
00610075097456OnliHOLLISTER INCORPORATEDGBM2026-02-01
00610075091928VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092581VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092598VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092604VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092611VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092628VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092635VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092642VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092659VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092666VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092673VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092680VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092697VaProHOLLISTER INCORPORATEDGBM2026-01-30
00610075092703VaProHOLLISTER INCORPORATEDGBM2026-01-30
10192253067651DoverCardinal Health 200, LLCKOD2025-04-14
10192253067668DoverCardinal Health 200, LLCKOD2025-04-14
10192253067675DoverCardinal Health 200, LLCKOD2025-04-14
10192253066289DoverCardinal Health 200, LLCKOD2024-09-04
10192253066296DoverCardinal Health 200, LLCKOD2024-09-04
10192253066302DoverCardinal Health 200, LLCKOD2024-09-04
10192253066319DoverCardinal Health 200, LLCKOD2024-09-04
10192253066326DoverCardinal Health 200, LLCKOD2024-09-04