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510(k) Data Aggregation
K Number
K222677Device Name
Intermittent nelaton catheter for single use
Manufacturer
Hangzhou Jimushi Meditech Co., Ltd.
Date Cleared
2023-04-05
(211 days)
Product Code
EZD
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Jimushi Meditech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.
Device Description
Intermittent nelaton catheter for single use is a disposable sterile catheter intended to be inserted through the urethra to the bladder for urine drainage. The target users are children (greater than 2 years of age), women and men. The catheter body is made of polyvinyl chloride (PVC) coated with gel lubricating substance. The distal end is either a smooth closed straight or coude tip and has two eyelets for efficient drainage. The funnel shaped color-coded connector at the proximal end can be connected to a urine collection container. There is a contact free device, which is for an easy grip, allowing for touchless insertion. The product is packaged in sealed plastic bags and sterilized with ethylene oxide.
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K Number
K200134Device Name
Jimushi Sterile Urethral Catheter for single use
Manufacturer
Hangzhou Jimushi Meditech Co., Ltd.
Date Cleared
2020-06-01
(132 days)
Product Code
GBM
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Jimushi Meditech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.
Device Description
Jimushi Sterile Urethral Catheter for single use is a disposable sterile catheter intended to be inserted through the urethra to the bladder for urine drainage. The target users are children (greater than 2 years of age), women and men. This product is supplied in three slightly different forms: 1) Common model (conventional uncoated type), 2) Hydrophilic coated model, 3) Hydrophilic coated with water pocket model. The catheter body is made of polyvinyl chloride (PVC) with or without hydrophilic coating. The distal end is either a smooth closed straight or coude tip with two eyelets for efficient drainage. The color-coded funnel shaped connector at the proximal end can be connected to a urine collection container. The catheter body is sterilized by EO, where the water pocket in some models is pre-sterilized by radiation.
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