FDA.reportPublic FDA data

RED Prep-Kit

Primary DI
B960RED202
Brand
RED Prep-Kit
Company
Neuraxis, Inc.
Model
02 2051 RED
Catalog number
02-2051
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.
Published
2025-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFQGauze/Sponge, Internal
FTYTape, Measuring, Rulers And Calipers
KKXDrape, Surgical
KMJLubricant, Patient
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1
KKXDrape, SurgicalGeneral, Plastic Surgery2
KMJLubricant, PatientGeneral Hospital1
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B960RED2020PackageHIBCC1Not in Commercial Distribution
B960RED2021PackageHIBCC1Not in Commercial Distribution
B960RED2022PackageHIBCC1Not in Commercial Distribution
B960RED2023PackageHIBCC5Not in Commercial Distribution
B960RED2024PackageHIBCC1In Commercial Distribution
B960RED2025PackageHIBCC1In Commercial Distribution
B960RED2026PackageHIBCC1Not in Commercial Distribution
B960RED2027PackageHIBCC2Not in Commercial Distribution
B960RED2028PackageHIBCC3Not in Commercial Distribution
B960RED2029PackageHIBCC4Not in Commercial Distribution
B960RED2030PackageHIBCC5Not in Commercial Distribution
B960RED2031PackageHIBCC1Not in Commercial Distribution
B960RED2032PackageHIBCC1Not in Commercial Distribution
B960RED202PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA 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.

Contacts#

Phone, Email table
PhoneEmail
812-689-0791Tcarrico@neuraxis.com

Regulatory Flags#

DUNS number
063076701
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B960RED201RED02 2050 RED02-20502025-01-09
B960NSS203NSS IB-STIMIB-STIM01-10202020-11-09
B960NSS200NSS-2 BridgeBridge01-1017-NSS-2/BRIDGE2021-02-12
B960NSS201NSS NeuroStimNeuroStim01-10212020-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160540862HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540886HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540916HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540923HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540930HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540947HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540954HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540961HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540978HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540985HalyardAVID MEDICAL, INC.LRO2026-10-20
00748426262069Medline-MicrotekMicrotek Medical LLCLRO2026-10-19
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