FDA.reportPublic FDA data

GENTLECATH GLIDE

Primary DI
00768455202249
Brand
GENTLECATH GLIDE
Company
CONVATEC, PURCHASING DEPARTMENT
Model
421565
Device description
GentleCath Glide Male CH10 (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
00768455202249PackageGS18In Commercial Distribution
00768455205325PackageGS130In Commercial Distribution
00768455204984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455202249007684552022497684552022490768455202249
00768455205325007684552053257684552053250768455205325
00768455204984007684552049847684552049840768455204984

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 Gauge10French

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
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
00768455101481ACTIVELIFE0227582018-11-09
00768455101498ACTIVELIFE0227592018-11-09
00768455101504ACTIVELIFE0227602018-11-09
00768455101511ACTIVELIFE0227612018-11-09
00768455101528ACTIVELIFE0227622018-11-16
00768455101535ACTIVELIFE0227632018-11-16
00768455101542ACTIVELIFE0227642018-11-16
00768455101559ACTIVELIFE0227652018-11-16
00768455101566ACTIVELIFE0227662018-11-16

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
00610075094394VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094400VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094424VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094431VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094448VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094462VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
10192253024326DoverCardinal Health 200, LLCKOD2024-02-29
10192253024333DoverCardinal Health 200, LLCKOD2024-02-29
10192253024357DoverCardinal Health 200, LLCKOD2024-02-29
10192253024319DoverCardinal Health 200, LLCKOD2024-02-09
10192253024340DoverCardinal Health 200, LLCKOD2024-02-09
10884521826403Mon-a-ThermCovidien LPKOD2023-05-29
10884521826410Mon-a-ThermCovidien LPKOD2023-05-29
10884521826427Mon-a-ThermCovidien LPKOD2023-05-29
10884521826434Mon-a-ThermCovidien LPKOD2023-05-29
10884521826441Mon-a-ThermCovidien LPKOD2023-05-29
10884521826458Mon-a-ThermCovidien LPKOD2023-05-29
10192253026825DoverCardinal Health 200, LLCKOD2022-08-04
10192253026238DoverCardinal Health 200, LLCKOD2022-06-07
10192253026245DoverCardinal Health 200, LLCKOD2022-06-07
10192253026252DoverCardinal Health 200, LLCKOD2022-06-07
10192253026269DoverCardinal Health 200, LLCKOD2022-06-07
10192253026283DoverCardinal Health 200, LLCKOD2022-06-07
10192253026290DoverCardinal Health 200, LLCKOD2022-06-07
10192253026306DoverCardinal Health 200, LLCKOD2022-06-07
10192253026313DoverCardinal Health 200, LLCKOD2022-06-07