Who else makes this device?

Name: Argon Arterial Line Kit
Brand: Argon Arterial Line Kit

General & Plastic Surgery › SurgicalGauze/Sponge, Internal, X-Ray Detectable

Argon Arterial Line Kit

Argon Arterial Line Kit 18ga x 6"

Registry build 21.09.26

67manufacturers in China registered for this device type

1catalogue number

7recalls on this code

Who Else Makes It

Concentrated in Jiangsu (18), Hubei (13), Zhejiang (12). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GDY
Manufacturer	City	Province	Registered as	Device types
Shanghai Joy Crown Industry Co., Ltd.	Pu Dong New Area	Shanghai	Contract manufacturer	64
Allmed Medical Products Co., Ltd.	Zhijiang	Hubei	Contract manufacturer	43
BH Medical Products Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	37
Jiangsu JianYu Health Medical Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	35
Jiangsu Guangda Medical Material Group Co., Ltd.	Haian	Jiangsu	Contract manufacturer	32
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd.	Jingmen	Hubei	Contract manufacturer	23
Derma Sciences Nantong Incorporation	Development	Jiangsu	Contract manufacturer	19
Kingstar Medical (Xianning) Co., Ltd.	Xianning	Hubei	Contract manufacturer	17
Zhejiang Aoki Medical Dressing Co., Ltd.	Wenzhou	Zhejiang	Contract manufacturer	16
Qingdao Likangyuan Medical Device Co., Ltd.	Qingdao	Shandong	Contract manufacturer	14
Winner Medical (Chongyang) Co., Ltd.	Chongyang	Hubei	Contract manufacturer	13
Suzhou Avon Textile Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	12

Showing 12 of 67. All 67 manufacturers in China registered for Gauze/Sponge, Internal, X-Ray Detectable

Record

Regulatory record for Argon Arterial Line Kit
Listed by	Argon Medical Devices, Inc., United States
FDA product code	GDY
Device type	Gauze/Sponge, Internal, X-Ray Detectable
Device class	Class 1
Regulation	21 CFR 878.4450
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
510(k)	K780871
Record published	2016-09-20
Record revised	2026-05-11 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Box of 10
Distribution end date	2024-04-16

Catalogue Numbers

Catalogue numbers for Argon Arterial Line Kit
Catalogue number	Size	Status
498405	18ga x 6″	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
AMD-Ritmed	AMD Medicom Inc.	248
DeRoyal	Deroyal Industries, Inc.	172
Situate	Covidien LP	60
Medical Action Industries	Medical Action Industries, Inc.	58
SurgiCount Safety-Sponge	Stryker GmbH	50
Dermapac, Inc.	Dermapac Inc.	48
Surgicount	Stryker GmbH	48
Dukal	Dukal LLC	46
Medline	Medline Industries, Inc.	41
ORLocate	Steris Corporation	35
A Plus	A Plus International, Inc	33
Pilling	Teleflex Medical LLC	31

Showing 12 of 82. All products under Gauze/Sponge, Internal, X-Ray Detectable

Recalls Naming This Product

6 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Argon Arterial Line Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Argon Medical Devices, Inc.	510(k) number	2026-06-01	Class I	Material/Component Contamination	Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.	440
Argon Medical Devices, Inc.	510(k) number	2022-01-24	Class II	Mixed-up of materials/components	Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.	600 ea
Argon Medical Devices, Inc.	510(k) number	2020-04-08	Class II	Under Investigation by firm	Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the us	150	2022-12-14
Argon Medical Devices, Inc.	510(k) number	2020-04-08	Class II	Under Investigation by firm	Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the us	20	2022-12-14
Argon Medical Devices, Inc.	510(k) number	2010-03-29	Not classified	Package design/selection	There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.	10 kits	2010-07-29
Argon Medical Devices, Inc.	510(k) number	2010-03-29	Not classified	Package design/selection	There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.	363 kits	2010-07-29

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-04-08	Class II	Under Investigation by firm	Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the us	80	2022-12-14

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.