Health Microport Endoscopic Bite Block

FDA Class I | 510(k) Exempt | Product Code MNK

The Endoscopic Bite Block holds the patient's mouth open and protects both the patient and the endoscope during upper GI endoscopy. Its curved design follows the contour of the mouth for patient comfort, and an adjustable strap keeps it securely in place throughout the procedure. Adult, pediatric, and oxygen-delivery versions are available, with mouth openings sized for different endoscopes.

Key Features

Curved, contoured design. The curved profile fits the mouth closely for better patient comfort during the procedure.

Adjustable strap included. Every model comes with an adjustable strap that holds the bite block securely in position and is quick to fit.

Medical-grade material. Made from medical-grade material suitable for oral contact, for patient comfort.

Adult and pediatric sizes. Different sizes and mouth openings suit adult and pediatric patients and a range of endoscope diameters.

Oxygen-delivery option. The oxygen bite block has an integrated port for supplemental oxygen during sedated procedures.

Intended Use

Used during endoscopic procedures to keep the patient's mouth open and protect the patient and the endoscope.

Specifications

Adult ┃ Model Number: HM/103-A1-B1 ┃ Strap: Included

Pediatric ┃ Model Number: HM/103-P1-B2 ┃ Strap: Included

Oxygen ┃ Model Number: HM/103-O ┃ Strap: Included

Gold ┃ Model Number: HM/103-G-4 ┃ Strap: Included

Yellow ┃ Model Number: HM/103-G-11 ┃ Strap: Included

Regulatory Information

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.

1. 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.

2. 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.

3. 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

4. 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.

5. 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

6. 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

7. 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.

8. 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.