What is FDA product code NXA?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Anesthesiology › TherapeuticTracheotomy Care Kit

Novaplus®

Name: Novaplus®
Brand: Novaplus®

Catalogue number 58911, listed by Medical Action Industries, Inc., United States, under Tracheotomy Care Kit. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (1), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NXA
Manufacturer	City	Province	Registered as	Device types
Taizhou Xinkang Medical Materials Co., Ltd.	Taizhou	Jiangsu	Contract manufacturer	35
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan	Hubei	Contract manufacturer	33

Record

Regulatory record for Novaplus®
Listed by	Medical Action Industries, Inc., United States
FDA product code	NXA
Device type	Tracheotomy Care Kit
Device class	Class 2
Regulation	21 CFR 868.5800
Premarket notification	Exempt
Record published	2016-08-20
Record revised	2020-10-21 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Over the counter	Yes
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Storage	Special storage condition: store at room temperature
Packaging	Pack of 24
Distribution end date	2019-02-26
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Novaplus®
Catalogue number	Size	Status
58911		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	88
Cardinal Health	Cardinal Health 200, LLC	46
Medical Action Industries	Medical Action Industries, Inc.	21
MedStream	Medical Specialties Distributors, Inc.	14
Busse Hospital Disposables	Robert Busse & Co., Inc.	11
Trinity Sterile, Inc.	Trinity Sterile, Inc.	6
Centurion Medical Products Corp	Medline Industries, Inc.	5
Medline	Medline Industries, Inc.	4
Moore Medical	Moore Medical Corp.	1
PHS	Medical Action Industries, Inc.	1

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.