AccessGUDID - DEVICE: RED Prep-Kit (B960RED202)

GUDID

Device Identifier (DI) Information

Brand Name: RED Prep-Kit
Version or Model: 02 2051 RED
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02-2051
Company Name: Neuraxis, Inc.

Primary DI Number: B960RED202
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 063076701 *Terms of Use

Device Description: The Rectal Expulsion Device Prep-kit (RED Prep-kit, PN 02-2051) consists of five (5) cartons and is to be used with the NeurAxis RED (PN 02-2050, UDI: B960RED201) device. Each of the five cartons 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTY	Tape, Measuring, Rulers And Calipers
KMJ	Lubricant, Patient
KKX	Drape, Surgical
LRO	General Surgery Tray
EFQ	Gauze/Sponge, Internal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3048278c-2082-48d9-bff4-5cc2dd798bc4
Public Version Date: March 10, 2025
Public Version Number: 7
DI Record Publish Date: January 09, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B960RED2020	1	B960RED202	2025-01-25	Not in Commercial Distribution	4 CARTONS
B960RED2021	1	B960RED2020	2025-01-25	Not in Commercial Distribution	BOX
B960RED2022	1	B960RED202	2025-01-25	Not in Commercial Distribution	CARTON
B960RED2023	5	B960RED2022	2025-01-25	Not in Commercial Distribution	BOX
B960RED2024	1	B960RED202		In Commercial Distribution	5 CARTONS
B960RED2025	1	B960RED2024		In Commercial Distribution	BOX