FDA.report

NELATION GENTLECATH

Primary DI
30768455143536
Brand
NELATION GENTLECATH
Company
CONVATEC, PURCHASING DEPARTMENT
Model
421566
Catalog number
421566
Device description
NEL GENTLECATH TPE CH12X16 IN
Published
2016-09-09
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

Related Records

Contact Domains

Product Codes

CodeName
KODCatheter, Urological

Product Code Classifications

CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00768455168613PackageGS110In Commercial Distribution
50768455143530PackageGS130In Commercial Distribution
70768455143534PackageGS18In Commercial Distribution
30768455143536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455168613007684551686137684551686130768455168613
5076845514353050768455143530
7076845514353470768455143534
3076845514353630768455143536

GMDN Terms

TermDefinition
Indwelling urethral drainage catheterA sterile, flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-422-8811cic@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 DIBrandModelCatalogPublished
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00768455204823GENTLECATH5106012024-04-05
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00768455207145GENTLECATH5106032024-04-05
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10768455203922ESTEEM4236432024-03-20
10768455203939ESTEEM4236442024-03-20
10768455203953ESTEEM4236462024-03-20
10768455203960ESTEEM4236472024-03-20
10768455203977ESTEEM4236482024-03-20
10768455204004ESTEEM4236512024-03-20
10768455204011ESTEEM4236522024-03-20
10768455204028ESTEEM4236532024-03-20
10768455204035ESTEEM4236542024-03-20
10768455204059ESTEEM4236562024-03-20

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