RED Prep-Kit 02-2051

GUDID B960RED202

The Rectal Expulsion Device Prep-kit (RED Prep-kit, PN 02-2051) consists of the following items and is to be used with the NeurAxis RED (PN 02-2050, UDI: B960RED201) device: 1) Extra-Large Heavy Absorbancy Disposible Underpads. 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) Sterile Disposable Ruler. Medline, DYNJRULER or similar. Product Code FTY.

Neuraxis, Inc.

General surgical procedure kit, non-medicated, single-use
Primary Device IDB960RED202
NIH Device Record Key3048278c-2082-48d9-bff4-5cc2dd798bc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameRED Prep-Kit
Version Model Number02 2051 RED
Catalog Number02-2051
Company DUNS063076701
Company NameNeuraxis, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB960RED202 [Primary]
HIBCCB960RED2020 [Package]
Package: 4 CARTONS [1 Units]
In Commercial Distribution
HIBCCB960RED2021 [Package]
Contains: B960RED2020
Package: BOX [1 Units]
In Commercial Distribution
HIBCCB960RED2022 [Package]
Package: CARTON [1 Units]
Discontinued: 2025-01-25
Not in Commercial Distribution
HIBCCB960RED2023 [Package]
Contains: B960RED2022
Package: BOX [5 Units]
Discontinued: 2025-01-25
Not in Commercial Distribution
HIBCCB960RED2024 [Package]
Package: 5 CARTONS [1 Units]
In Commercial Distribution
HIBCCB960RED2025 [Package]
Contains: B960RED2024
Package: BOX [1 Units]
In Commercial Distribution
HIBCCB960RED2026 [Package]
Package: CARTON [1 Units]
In Commercial Distribution
HIBCCB960RED2027 [Package]
Package: CARTON [2 Units]
In Commercial Distribution
HIBCCB960RED2028 [Package]
Package: CARTON [3 Units]
In Commercial Distribution
HIBCCB960RED2029 [Package]
Package: CARTON [4 Units]
In Commercial Distribution
HIBCCB960RED2030 [Package]
Package: CARTON [5 Units]
In Commercial Distribution

FDA Product Code

FTYTape, Measuring, Rulers And Calipers

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-17
Device Publish Date2025-01-09

Devices Manufactured by Neuraxis, Inc.

B960RED201 - RED2025-01-17 The Rectal Expulsion Device (RED) is a catheter with a proprietary open-cell foam balloon that naturally expands when inserted i
B960RED202 - RED Prep-Kit2025-01-17The Rectal Expulsion Device Prep-kit (RED Prep-kit, PN 02-2051) consists of the following items and is to be used with the NeurAxis RED (PN 02-2050, UDI: B960RED201) device: 1) Extra-Large Heavy Absorbancy Disposible Underpads. 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) Sterile Disposable Ruler. Medline, DYNJRULER or similar. Product Code FTY.
B960RED202 - RED Prep-Kit2025-01-17 The Rectal Expulsion Device Prep-kit (RED Prep-kit, PN 02-2051) consists of the following items and is to be used with the NeurA
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