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RED Prep-Kit

FDA UDI

Class I (US FDA UDI)

by Neuraxis, Inc

Identity

Trade Name
RED Prep-Kit FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
02 2051 RED FDA UDI
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. FDA UDI

Identifiers

Catalog Number
02-2051 FDA UDI
Primary DI / UDI-DI
B960RED202 FDA UDI
FDA Product Code
FTY FDA UDI
KMJ FDA UDI
KKX FDA UDI
LRO FDA UDI
EFQ FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
880.6375 FDA UDI
878.4370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

RED Prep-Kit by Neuraxis, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neuraxis, Inc

Sources (1)

  • FDA UDI 3048278c-2082-48d9-bff4-5cc2dd798bc4 35 fields · synced May 30, 2026