Dermacinrx Surgical Combopak Kit
NDC Package 59088-334-00

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

Package Information

Dermacinrx Surgical Combopak (chlorhexidine gluconate surgical combo kit) kits is use with care in premature infants and infants under 2 months of age. This formulation utilizes a kit delivery system. Marketed by Puretek Corporation, this product is identified by NDC 59088-334.

Identification & Billing

NDC Package Code
59088-334-00
Package Description
1 KIT in 1 PACKAGE * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 118 mL in 1 TUBE (59088-333-08)
Product Code
59088-334
11-Digit Billing Format
59088033400
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dermacinrx Surgical Combopak
Non-Proprietary Name
Chlorhexidine Gluconate Surgical Combo Kit
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.Surgical hand scrub:wet hands and forearms with waterscrub for 3 minutes with about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spacesa separate nail cleaner may be usedrinse thoroughlywash for an additional 3 minutes with 5 ml of product and rinse under running waterdry thoroughlyHealthcare personnel handwash:wet hands with waterdispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 secondsrinse and dry thoroughlyPatient preoperative skin preparation:apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towelrepeat procedure for an additional 2 minutes and dry with a sterile towelSkin wound and general skin cleaning:thoroughly rinse the area to be cleaned with waterapply the minimum amount of product necessary to cover the skin or wound area and wash gentlyrinse again thoroughly ■ apply cream liberally as needed

Regulatory & Marketing

Labeler Name
Puretek Corporation
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
04-28-2015
Listing Expiration
12-31-2026
Exclude Flag
N
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 59088-334-00 identifies a specific commercial package of 1 kit in 1 package * 237 ml in 1 bottle, plastic (0116-1061-08) * 118 ml in 1 tube (59088-333-08) of Dermacinrx Surgical Combopak, a human prescription drug labeled by Puretek Corporation. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Puretek Corporation on April 28, 2015. The current certification is valid through December 31, 2026.

How is this Puretek Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59088033400. 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)
59088-334-00
11-Digit CMS (5-4-2)
59088-0334-00

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