Qcare Oral Cleansing And Suctioning System, Q4
NDC Package 53462-424-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Qcare Oral Cleansing And Suctioning System, Q4 is before opening, turn package over, burst solution packet with thumbs. Marketed by Sage Products, Llc, this product is identified by NDC 53462-424 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
53462-424-60
Package Description
1 KIT in 1 KIT * 2 PACKET in 1 KIT / 7 mL in 1 PACKET (53462-275-60) * 6 PACKET in 1 KIT / 2 g in 1 PACKET * 4 PACKET in 1 KIT / 7 mL in 1 PACKET (53462-075-60)
Product Code
53462-424
11-Digit Billing Format
53462042460
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Qcare Oral Cleansing And Suctioning System, Q4
Dosage Form
-
Usage Information
Before opening, turn package over, burst solution packet with thumbs. Peel lid to open.Remove Mouth Moisturizer and Applicator Swab.Attach Suction Swab to suction line.Clean teeth and oral cavity for approximately one minute.To suction, place thumb over port.To clear tubing, rinse with sterile saline or appropriate solution.Discard Suction Swab. Reattach Covered Yankauer to suction line.Place Mouth Moisturizer on Applicator Swab.Apply as needed to lips and inside mouth.Use up to 4 times daily or as directed by a dentist or doctor.Children under 12 years of age: supervise use.Children under 3 years of age: consult a dentist or doctor.Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. If not, remove any particles from oral cavity. Suction Toothbrush with Antiplaque Solution:Before opening, turn package over, burst solution packet with thumbs. Peel lid to open.Remove Mouth Moisturizer and Applicator Swab.Attach Toothbrush to suction line.Clean teeth and oral cavity for approximately one minute.To suction, place thumb over port.To clear tubing, rinse with sterile saline or appropriate solution.Discard Toothbrush. Reattach Covered Yankauer to suction line.Place Mouth Moisturizer on Applicator Swab.Apply as needed to lips and inside mouth.Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution.Children ages 6 to 12 years: supervise use.Children under 6 years of age: do not use.Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. If not, remove any particles from oral cavity.Oropharyngeal Suction Catheter:Peel lid to open.Attach Suction Catheter to suction line.Suction secretions from the oropharyngeal cavity.To suction, place thumb over port.To clear tubing, rinse with sterile saline or appropriate solution.Discard Suction Catheter. Reattach Covered Yankauer to suction line.Use bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.CautionFederal (U.S.A.) law restricts this device to sale by or on the order of a physician or licensed practitioner.

Regulatory & Marketing

Labeler Name
Sage Products, Llc
FDA Application #
part356
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
06-30-2008
Listing Expiration
12-31-2021
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53462-424-60 identifies a specific commercial package of 1 kit in 1 kit * 2 packet in 1 kit / 7 ml in 1 packet (53462-275-60) * 6 packet in 1 kit / 2 g in 1 packet * 4 packet in 1 kit / 7 ml in 1 packet (53462-075-60) of Qcare Oral Cleansing And Suctioning System, Q4, labeled by Sage Products, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sage Products, Llc on June 30, 2008. The current certification is valid through December 31, 2021.

How is this Sage Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53462042460. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
53462-424-60
11-Digit CMS (5-4-2)
53462-0424-60

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.