Health Microport Disposable Multi-Chamber Polyp Trap
Health Microport Disposable Multi-Chamber Polyp Trap
FDA Class II | 510(k) Exempt | Product Code KDQ | Sterile | Single Use | Rx Only
The Disposable Multi-Chamber Polyp Trap is a sterile, single-use accessory that simplifies polyp collection and improves specimen handling during colonoscopy. It connects to the suction line, and its fine-mesh screen captures even small polyps. Numbered, individually removable chambers keep multiple specimens separate, so each can be labeled and sent for pathology.
Key Features
Fine-mesh screen. The fine filter captures small polyps and tissue fragments reliably.
Multiple removable chambers. Four or five individually removable chambers collect separate specimens in a single procedure.
Clear position indicators. Each chamber is clearly numbered, so specimens can be matched to their collection sites.
Visual verification. The transparent housing lets the clinician confirm that a polyp has been collected.
Sealing cover. A sealing cover protects collected specimens from contamination.
Individually sterile-packed. Each trap is sterile-packed separately for single use. This removes the need for reprocessing and lowers the risk of cross-contamination between patients.
Intended Use
Collection of polyps and colonoscopy specimens.
Specifications
5-Chamber ┃ Model Number: HM/802-1 ┃ Chambers: 5 individually removable ┃ Packaging: Individually sterile-packed
4-Chamber ┃ Model Number: HM/802-2 ┃ Chambers: 4 individually removable ┃ Packaging: Individually sterile-packed
Regulatory Information
FDA Device Class Class II
Product Code KDQ (Bottle, Collection, Vacuum)
Regulation 21 CFR 880.6740
Premarket Status 510(k) Exempt
FDA Device Listing D273720
For professional use only. Sold exclusively to hospitals, clinics, and other licensed healthcare institutions. Read the Instructions for Use before use.
Warranty Policy
Medaza, Inc.
- Product Scope
This product is intended solely for use by licensed clinics, hospitals, laboratories, and research facilities for professional or institutional human-use applications. It is not labeled, marketed, or warranted for consumer or home use, and is not intended for resale to individual end users.
- Limited Manufacturer Warranty
This product is warranted by the original manufacturer to be free from defects in materials and workmanship at the time of shipment, when stored, handled, and used in accordance with the manufacturer's Instructions for Use (IFU) and labeling.
- Single-Use / Consumable Exclusion
This is a single-use, sterile medical consumable intended for one-time use. As a consumable product, it is:
Not covered by any warranty once the sterile packaging has been opened, the product has been used, or the expiration/use-by date has passed
Not eligible for return, replacement, or refund based on buyer's change of mind, over-ordering, or discontinued use, once shipped and accepted
Excluded from any implied warranty of merchantability or fitness for a particular purpose beyond what is required by applicable law
- What IS Covered
Notwithstanding Section 3, this warranty does apply, and Medaza, Inc. will facilitate a replacement, credit, or refund through the manufacturer, where:
The product arrives with compromised sterile packaging (torn, punctured, or improperly sealed) at time of receipt
The product exhibits a manufacturing defect present prior to use (e.g., material failure, dimensional nonconformity, malfunction not attributable to misuse, improper storage, or mishandling by buyer)
The product was not as described on the invoice or packing slip (wrong configuration, size, or gauge shipped in error)
Claims under this section must be submitted within 3 business days of receipt (unopened packaging defects) or promptly upon discovery of a manufacturing defect, and must include lot number, photographs, and a description of the issue. Medaza, Inc. reserves the right to require return of the affected unit(s) for manufacturer inspection prior to issuing replacement or credit.
- Exclusions
This warranty does not cover damage or nonconformity resulting from:
Improper storage (e.g., temperature excursion, exposure to moisture or contaminants)
Use beyond the labeled expiration date
Improper handling, technique, or clinical misuse
Alteration or modification of the product by buyer or any third party
Normal wear expected in single-use consumables
- Field Safety Corrective Actions and Recalls
In the event the manufacturer or a regulatory authority (including but not limited to the U.S. FDA Center for Devices and Radiological Health, or applicable state authority) issues a recall, field safety notice, or field safety corrective action affecting this product:
Medaza, Inc. will notify affected buyers using the contact and shipment records on file, relying on lot/batch traceability maintained under Medaza, Inc.'s Quality Management System
Buyers are required to immediately quarantine and cease use of any affected lots upon notification, and to cooperate with return, disposition, or reporting instructions provided
Buyers must report any adverse events or product complaints associated with this product to Medaza, Inc. promptly, so that Medaza, Inc. can fulfill its complaint-handling obligations to the manufacturer and, where applicable, to regulatory authorities
Participation in a recall or field safety corrective action does not waive, and is separate from, the warranty terms above — recalled product is addressed under recall procedures, not warranty claims
- Limitation of Liability
Except as expressly stated above, this product is provided on an "as-is" basis to the extent permitted by applicable law. Medaza, Inc.'s liability under this warranty is limited to replacement, credit, or refund of the affected unit(s), and Medaza, Inc. is not liable for indirect, incidental, or consequential damages arising from use of this product.
- Governing Terms
This Warranty Policy operates alongside, and does not limit, Medaza, Inc.'s Terms of Service, Shipping Policy, and applicable human medical device regulatory obligations under DSHS and FDA frameworks, including, where applicable, FDA 510(k) clearance requirements.
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