RED Prep-Kit

Basic Information

• Brand Name: RED Prep-Kit
• Primary DI: B960RED202
• Version / Model: 02 2051 RED
• Catalog Number: 02-2051
• Company Name: Neuraxis, Inc.
• Labeler DUNS: 063076701
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-09
• Public Version: 10
• Public Version Date: 2025-09-22
• Public Version Status: Update
• Public Device Record Key: 3048278c-2082-48d9-bff4-5cc2dd798bc4

Device Description

The Rectal Expulsion Device Prep-kit (RED Prep-kit, PN 02-2051) consists of one to five (1-5) cartons and is to be used with the NeurAxis RED (PN 02-2050, UDI: B960RED201) device. Each carton contains the following items: 1) One (1) pack of Extra-Large Heavy Absorbency Disposable Under-pads. Medline, MSC282070LB or similar. Product Code LRO. 2) Two (2) tubes of single use Lubricating Jelly. Medline, MDS032280 or similar. Product Code KMJ. 3) Two (2) packs of 10/hard tray Woven Sterile Gauze Sponges 4"x4", 12-ply. Medline, NON21426 or similar. Product Code EFQ. 4) One (1) pack of five (5) Ready Bath Select Bathing cloths 8x8 inch. Medline, MSC095109 or similar. Product Code KKX. 5) One (1) Sterile Skin Marker with Ruler. Medline, DYNJSM01 or similar. Product Code FTY. 6) One Instructions For Use [IFU] (LBL6014). Minimum 1 IFU/Box. Note: Box contains 1-5 cartons.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	878.4800	1
KMJ	Lubricant, Patient	General Hospital	880.6375	1
KKX	Drape, Surgical	General, Plastic Surgery	878.4370	2
LRO	General Surgery Tray	General, Plastic Surgery	878.4370	2
EFQ	Gauze/Sponge, Internal	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
33961	General surgical procedure kit, non-medicated, single-use	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B960RED202	HIBCC
Package	B960RED2020	HIBCC	4 CARTONS	1	Not in Commercial Distribution	2025-01-25
Package	B960RED2021	HIBCC	BOX	1	Not in Commercial Distribution	2025-01-25
Package	B960RED2022	HIBCC	CARTON	1	Not in Commercial Distribution	2025-01-25
Package	B960RED2023	HIBCC	BOX	5	Not in Commercial Distribution	2025-01-25
Package	B960RED2024	HIBCC	5 CARTONS	1	In Commercial Distribution
Package	B960RED2025	HIBCC	BOX	1	In Commercial Distribution
Package	B960RED2026	HIBCC	CARTON	1	Not in Commercial Distribution	2025-09-19
Package	B960RED2027	HIBCC	CARTON	2	Not in Commercial Distribution	2025-09-19
Package	B960RED2028	HIBCC	CARTON	3	Not in Commercial Distribution	2025-09-19
Package	B960RED2029	HIBCC	CARTON	4	Not in Commercial Distribution	2025-09-19
Package	B960RED2030	HIBCC	CARTON	5	Not in Commercial Distribution	2025-09-19

Customer Contacts

• Phone: [phone]
• Email: [email protected]