FDA.reportPublic FDA data

BeneCath®

Primary DI
06972624970172
Brand
BeneCath®
Company
Hangzhou Jimushi Meditech Co., Ltd.
Model
NCW16F
Published
2021-01-01
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

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
06972624970172PackageGS130In Commercial Distribution
26972624970176PackageGS110In Commercial Distribution
16972624970179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972624970172069726249701726972624970172
2697262497017626972624970176
1697262497017916972624970179

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
413190154
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
true
Sterilization required before use
false

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
16972624970186BeneCath®NCW18F2021-01-01
16972624970193BeneCath®NCW08P2021-01-01
16972624970209BeneCath®NCW10P2021-01-01
16972624970254BeneCath®NCH08M2021-01-01
16972624970261BeneCath®NCH10M2021-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14026704922670RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922687RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922694RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922700RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922717RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922724RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922731RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922748RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945433RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945440RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945457RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945464RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945471RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945488RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945495RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945501RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945518RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945815RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945822RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945839RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945853RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945860RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945877RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945884RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945891RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945907RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945914RUSCHTELEFLEX INCORPORATEDGBM2026-07-28