FDA.reportPublic FDA data

BeneCath®

Primary DI
16972624970186
Brand
BeneCath®
Company
Hangzhou Jimushi Meditech Co., Ltd.
Model
NCW18F
Published
2021-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBMCatheter, Urethral

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972624970189PackageGS130In Commercial Distribution
26972624970183PackageGS110In Commercial Distribution
16972624970186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972624970189069726249701896972624970189
2697262497018326972624970183
1697262497018616972624970186

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral drainage catheter, non-antimicrobial, single-useA flexible or rigid tube designed for a single insertion into the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide urine drainage, typically for an individual who is physiologically incapable of voiding. The device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass] and is disposed of after use; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a single-use device.

Regulatory Flags#

DUNS number
413190154
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16972624970025BeneCath®NCW10M2021-01-01
16972624970032BeneCath®NCW12M2021-01-01
16972624970056BeneCath®NCW16M2021-01-01
16972624970063BeneCath®NCW18M2021-01-01
16972624970070BeneCath®NCW08MC2021-01-01
16972624970087BeneCath®NCW10MC2021-01-01
16972624970094BeneCath®NCW12MC2021-01-01
16972624970100BeneCath®NCW14MC2021-01-01
16972624970117BeneCath®NCW16MC2021-01-01
16972624970124BeneCath®NCW18MC2021-01-01
16972624970131BeneCath®NCW08F2021-01-01
16972624970148BeneCath®NCW10F2021-01-01
16972624970155BeneCath®NCW12F2021-01-01
16972624970162BeneCath®NCW14F2021-01-01
16972624970179BeneCath®NCW16F2021-01-01
16972624970193BeneCath®NCW08P2021-01-01
16972624970209BeneCath®NCW10P2021-01-01
16972624970254BeneCath®NCH08M2021-01-01
16972624970261BeneCath®NCH10M2021-01-01
16972624970278BeneCath®NCH12M2021-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14026704945914RUSCHTELEFLEX INCORPORATEDGBM2026-07-28