Jimushi Sterile Urethral Catheter for Single Use
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200134 FDA 510(k)
- FDA Product Code
- GBM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5130 FDA 510(k)
- Regulation Number
- 876.5130 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A sterile, single-use urethral catheter designed for urinary drainage. This device falls under the nomenclature category of a Catheter, Urethral, intended for temporary or intermittent bladder drainage in clinical settings.
Supplied in a sterile, single-use packaging, the catheter is intended for hospital or clinical use only. It adheres to FDA 510(k) and MDR regulatory standards, with a classification under Regulation 876.5130 and Product Code GBM. Multiple sizes are available, as referenced in the regulatory filings, and the device is non-reusable. No MRI safety information is specified in the provided data.
Frequently asked questions
What clinical scenarios is the Jimushi Sterile Urethral Catheter designed for, and how does its single-use nature benefit patients or facilities?
The Jimushi Sterile Urethral Catheter is specifically designed for temporary or intermittent bladder drainage in clinical settings, such as hospitals. Its single-use nature ensures sterility and reduces the risk of cross-contamination or infection, which is critical in medical environments where hygiene is paramount. This design also eliminates the need for reprocessing, streamlining workflows and ensuring consistent performance for each patient use.
Are there multiple sizes available for the Jimushi Sterile Urethral Catheter, and how can I determine which size is appropriate for a patient?
Yes, the Jimushi Sterile Urethral Catheter comes in multiple sizes, as indicated by the extensive list of registration numbers and the regulatory filings under Product Code GBM. The appropriate size depends on patient-specific factors such as age, gender, and anatomical considerations. Clinicians should refer to standard medical guidelines or consult the manufacturer’s sizing chart (if available) to select the correct catheter size for optimal comfort and functionality.
How should the Jimushi Sterile Urethral Catheter be stored, and what precautions should be taken to maintain its sterility?
The catheter is supplied in sterile, single-use packaging, so it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. The packaging should remain intact until use to preserve sterility. Avoid storing it in areas with high humidity or near chemicals, as these conditions could compromise the device’s integrity or sterility.
Is the Jimushi Sterile Urethral Catheter safe for use in patients who require MRI scans, and what should clinicians consider before ordering?
The provided data does not specify MRI safety information for the Jimushi Sterile Urethral Catheter, meaning its compatibility with MRI procedures has not been explicitly addressed. Clinicians should verify compatibility with the manufacturer or consult MRI safety guidelines before using this catheter in patients scheduled for an MRI scan to avoid potential risks.
What regulatory pathways does the Jimushi Sterile Urethral Catheter follow, and how does this affect its availability or use in different markets?
The catheter follows both FDA 510(k) and MDR (Medical Device Regulation) pathways, indicating it has undergone evaluations for compliance with U.S. and European Union standards, respectively. This dual regulatory clearance allows for availability in markets adhering to these frameworks, such as the U.S. and EU. However, clinicians or buyers should confirm local regulatory requirements and compliance documentation before procurement or use, as additional approvals may be needed for specific regions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Jimushi Sterile Urethral Catheter for single use - BEUDAMED, Jimushi Sterile Urethral Catheter For Single Use… - FDA.report, Hangzhou Jimushi Meditech Co., Ltd. FDA 510 (k) Products, PDF Wei June - Food and Drug Administration
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K200134 | Class II | Active |
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Manufacturer
- Manufacturer
- Hangzhou Jimushi Meditech Co., Ltd.
Sources (2)
- FDA 510(k) K200134 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026