RED Prep-Kit

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…

Registry build 21.09.26

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 8×8 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.

42manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (14), Zhejiang (10), Shanghai (9). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FTY
Manufacturer City Province Registered as Device types
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Derma Sciences Nantong Incorporation Development Jiangsu Contract manufacturer 19
Chartek Electronic (Yang Zhou) Ltd Yangzhou City, Jiansu Jiangsu Contract manufacturer 6
Nanjing Easthigh Measurement Co Ltd Nanjing Jiangsu Contract manufacturer 5
YU XIN Technology(Huizhou) Co., Ltd. Huizhou Guangdong Contract manufacturer 5
Wuxi Weigher Factory Co., Ltd. Wuxi Jiangsu Contract manufacturer 4
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71

Showing 12 of 42. All 42 manufacturers in China registered for Tape, Measuring, Rulers And Calipers

Record

Regulatory record for RED Prep-Kit
Listed by Neuraxis, Inc, United States
FDA product code FTY
Device type Tape, Measuring, Rulers And Calipers
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Complaint-file establishment, Manufacturer
Record published 2025-01-09
Record revised 2025-09-22 (version 10)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Supplied as a kit Yes
Label carries expiry date, manufacturing date
Packaging Box, carton, 4 cartons, box of 5, 5 cartons, carton of 2

Catalogue Numbers

Catalogue numbers for RED Prep-Kit
Catalogue number Size Status
02 2051 RED In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Power Dental USA Power Dental U.S.A. Inc. 42
Tape, Measuring, Rulers And Calipers Black & Black Surgical, Inc. 33
Surtex Surtex Instruments Ltd 28
Charder Charder Electronic Co., Ltd. 26
Trigen Smith & Nephew, Inc. 24
Surgical Direct Surgical Direct, Inc. 24
American Medicals American Medicals 21
Marina Medical Marina Medical Instruments, Inc. 20
Millennium Avalign Technologies, Inc. 18
Integra® Miltex® Integra LifeSciences Production Corporation 15
Bausch + Lomb Bausch & Lomb Incorporated 15
Ambler Surgical Ambler Surgical, LLC 15

Showing 12 of 272. All products under Tape, Measuring, Rulers And Calipers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer