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.

Medline · Tracheotomy Care Kit → Anesthesiology

Name: Medline
Brand: Medline

2manufacturers in China registered for this device type

4catalogue numbers in this listing

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 Medline
Listed by	Medline 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	2020-05-11
Record revised	2022-06-17 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
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 20, case of 20
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Medline
Catalogue number	Size	Status
P856585		In distribution
DYND40650		In distribution
DYNDA1482		In distribution
DYNDJ1007		In distribution

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
Moore Medical	Moore Medical Corp.	1
PHS	Medical Action Industries, Inc.	1
Novaplus®	Medical Action Industries, Inc.	1

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Medline
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medline Industries, LP – Northfield	UDI-DI	2023-11-15	Class I	Nonconforming Material/Component	Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As	2683387 units

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.

Medline