Who else makes this device?

Name: Medallion®
Brand: Medallion®

General Hospital › TherapeuticSyringe, Piston

Medallion®

223 catalogue numbers from 00884450609910, listed by Merit Medical Systems, Inc., United States, under Syringe, Piston. 60 manufacturers in China are registered for this product code.

Registry build 21.09.26

60manufacturers in China registered for this device type

223catalogue numbers in this listing

10510(k) clearances naming this product code

20recalls on this code

Who Else Makes It

Concentrated in Jiangsu (16), Zhejiang (15), Shanghai (11). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FMF
Manufacturer	City	Province	Registered as	Device types
Jiangsu Caina Medical Co., Ltd.	Jiangyin	Jiangsu	Contract manufacturer	20
BQ Plus Medical Co., Ltd.	Songjiang	Shanghai	Contract manufacturer	13
Medwell Technology Limited	Dongguan	Guangdong	Contract manufacturer	10
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.	Chengdu	Sichuan	Contract manufacturer	10
Zhejiang Runqiang Medical Instruments Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	9
Wuxi Yushou Medical Appliances Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	8
Pine Moon Electronics Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
Shenzhen HYS Medical Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6
Yangzhou Xingwei Medical Technology Co., Ltd.	Yangzhou	Jiangsu	Contract manufacturer	5
Zhejiang INI Medical Devices Co., Ltd.	Wenzhou	Zhejiang	Contract manufacturer	4
ShanDong WeiGao Group Medical Polymer Co., Ltd.	Weihai	Shandong	Contract manufacturer	3
Hantech (Ningbo) Medical Technology Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	3

Showing 12 of 60. All 60 manufacturers in China registered for Syringe, Piston

Record

Regulatory record for Medallion®
Listed by	Merit Medical Systems, Inc., United States
FDA product code	FMF
Device type	Syringe, Piston
Device class	Class 2
Regulation	21 CFR 880.5860
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2022-05-03
Record revised	2025-03-28 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Packaging	Pack of 25, pack of 4, pack of 20, pack of 200

Catalogue Numbers

Catalogue numbers for Medallion®
Catalogue number	Size	Status
00884450609910	Size (Volume)-6 mL	In distribution
00884450402214		In distribution
00884450029978	Size (Volume)-10 mL; Plunger Color-Light Green; Size (Volume)-10 mL	In distribution
00884450050569	Size (Volume)-60 mL	In distribution
00884450402795	Size (Volume)-20 mL	In distribution
00884450029374	Size (Volume)-20 mL	In distribution
00884450610329	Size (Volume)-20 mL	In distribution
00884450609743	Size (Volume)-3 mL	In distribution
00884450402450	Size (Volume)-10 mL	In distribution
00884450022887	Size (Volume)-3 mL	In distribution
00884450402122		In distribution
00884450025789	Size (Volume)-10 mL	In distribution
00884450610282	Size (Volume)-1 mL	In distribution
00884450019641	Size (Volume)-30 mL	In distribution
00884450609750	Size (Volume)-3 mL	In distribution
00884450401880		In distribution
00884450610213	Size (Volume)-30 mL	In distribution
00884450402900		In distribution
00884450610503	Size (Volume)-20 mL	In distribution
00884450543924		In distribution
00884450402153		In distribution
00884450610350	Size (Volume)-10 mL	In distribution
00884450402665	Size (Volume)-10 mL	In distribution
00884450609712	Size (Volume)-1 mL	In distribution
00884450113912	Plunger Color-Yellow; Size (Volume)-20 mL; Plunger Color-Yellow	In distribution
00884450028285	Plunger Color-Light Green; Size (Volume)-10 mL; Plunger Color-Light Green	In distribution
00884450402887		In distribution
00884450610312	Size (Volume)-10 mL	In distribution
00884450610336	Size (Volume)-60 mL	In distribution
00884450609866	Size (Volume)-6 mL	In distribution
00884450028292	Plunger Color-Yellow	In distribution
00884450402917	Size (Volume)-20 mL	In distribution
00884450610411	Size (Volume)-10 mL	In distribution
00884450402108	Size (Volume)-3 mL	In distribution
00884450402177		In distribution
00884450109885	Size (Volume)-10 mL	In distribution
00884450021750	Plunger Color-Light Green; Size (Volume)-10 mL; Plunger Color-Light Green	In distribution
00884450401903		In distribution
00884450021774	Size (Volume)-10 mL; Plunger Color-Red; Size (Volume)-10 mL	In distribution
00884450106020	Size (Volume)-20 mL	In distribution
00884450006771	Size (Volume)-20 mL	In distribution
00884450610268	Size (Volume)-60 mL	In distribution
00884450610428	Size (Volume)-10 mL	In distribution
00884450055502	Size (Volume)-20 mL; Plunger Color-Light Green; Size (Volume)-20 mL	In distribution
00884450021712	Size (Volume)-3 mL; Plunger Color-Dark Green; Size (Volume)-3 mL	In distribution
00884450609651	Size (Volume)-1 mL	In distribution
00884450021743	Plunger Color-Light Green; Size (Volume)-10 mL; Plunger Color-Light Green	In distribution
00884450050255	Size (Volume)-1 mL	In distribution
00884450013793	Size (Volume)-1 mL	In distribution
00884450402818		In distribution
00884450609705	Size (Volume)-1 mL	In distribution
00884450052730	Size (Volume)-30 mL; Plunger Color-Yellow; Size (Volume)-30 mL	In distribution
00884450023716	Size (Volume)-3 mL	In distribution
00884450402023		In distribution
00884450402658	Size (Volume)-10 mL	In distribution
00884450025796	Plunger Color-Light Blue; Size (Volume)-10 mL; Plunger Color-Light Blue	In distribution
00884450096154	Size (Volume)-10 mL; Plunger Color-Dark Green; Size (Volume)-10 mL	In distribution
00884450610244	Size (Volume)-30 mL	In distribution
00884450007365	Size (Volume)-1 mL	In distribution
00884450402726	Size (Volume)-10 mL	In distribution
00884450019658	Size (Volume)-30 mL	In distribution
00884450609859	Size (Volume)-6 mL	In distribution
00884450402801		In distribution
00884450402160		In distribution
00884450007051	Size (Volume)-3 mL	In distribution
00884450114353	Size (Volume)-10 mL	In distribution
00884450610251	Size (Volume)-60 mL	In distribution
00884450402757		In distribution
00884450024331	Plunger Color-White	In distribution
00884450402443	Size (Volume)-10 mL	In distribution
00884450052778	Size (Volume)-20 mL; Plunger Color-Light Blue; Size (Volume)-20 mL	In distribution
00884450007075	Size (Volume)-6 mL	In distribution
00884450023631	Plunger Color-Light Blue; Size (Volume)-10 mL; Plunger Color-Light Blue	In distribution
00884450610466	Size (Volume)-20 mL	In distribution
00884450046456	Plunger Color-Yellow; Size (Volume)-20 mL; Plunger Color-Yellow	In distribution
00884450401927		In distribution
00884450610497	Size (Volume)-20 mL	In distribution
00884450609729	Size (Volume)-1 mL	In distribution
00884450046302	Size (Volume)-6 mL	In distribution
00884450610084	Size (Volume)-20 mL	In distribution
00884450402085		In distribution
00884450006849	Size (Volume)-30 mL	In distribution
00884450121788	Size (Volume)-20 mL	In distribution
00884450052785	Plunger Color-Light Green; Size (Volume)-20 mL; Plunger Color-Light Green	In distribution
00884450102398	Size (Volume)-20 mL	In distribution
00884450025932	Size (Volume)-20 mL	In distribution
00884450011287	Plunger Color-Red; Size (Volume)-10 mL; Plunger Color-Red	In distribution
00884450050552	Size (Volume)-1 mL	In distribution
00884450117255	Size (Volume)-20 mL	In distribution
00884450112748	Size (Volume)-10 mL	In distribution
00884450609682	Size (Volume)-1 mL	In distribution
00884450007198	Size (Volume)-6 mL	In distribution
00884450402771		In distribution
00884450609903	Size (Volume)-6 mL	In distribution
00884450101803	Size (Volume)-10 mL	In distribution
00884450053997	Size (Volume)-10 mL	In distribution
00884450610176	Size (Volume)-30 mL	In distribution
00884450019535	Size (Volume)-3 mL; Plunger Color-Light Blue; Size (Volume)-3 mL	In distribution
00884450028278	Plunger Color-Light Blue; Size (Volume)-10 mL; Plunger Color-Light Blue	In distribution
00884450117446	Size (Volume)-10 mL	In distribution
00884450402566	Size (Volume)-10 mL	In distribution
00884450402115		In distribution
00884450610299	Size (Volume)-3 mL	In distribution
00884450610237	Size (Volume)-30 mL	In distribution
00884450609668	Size (Volume)-1 mL	In distribution
00884450103906	Size (Volume)-10 mL	In distribution
00884450104439	Size (Volume)-10 mL	In distribution
00884450610053	Size (Volume)-20 mL	In distribution
00884450402832		In distribution
00884450023624	Size (Volume)-10 mL; Plunger Color-Dark Green; Size (Volume)-10 mL	In distribution
00884450076484	Size (Volume)-6 mL	In distribution
00884450019627	Size (Volume)-6 mL	In distribution
00884450025949	Size (Volume)-30 mL	In distribution
00884450095942	Size (Volume)-10 mL	In distribution
00884450552360		In distribution
00884450610459	Size (Volume)-20 mL	In distribution
00884450402849		In distribution
00884450021736	Plunger Color-Light Blue	In distribution
00884450610190	Size (Volume)-30 mL	In distribution
00884450610183	Size (Volume)-30 mL	In distribution
00884450008294	Size (Volume)-6 mL	In distribution
00884450028261	Plunger Color-White; Size (Volume)-10 mL; Plunger Color-White	In distribution
00884450402580	Size (Volume)-10 mL	In distribution
00884450610275	Size (Volume)-60 mL	In distribution
00884450029350	Size (Volume)-3 mL	In distribution
00884450402733	Size (Volume)-20 mL	In distribution
00884450109946	Size (Volume)-10 mL	In distribution
00884450011409	Size (Volume)-60 mL	In distribution
00884450119273	Size (Volume)-20 mL	In distribution
00884450007044	Size (Volume)-1 mL	In distribution
00884450609835	Size (Volume)-3 mL	In distribution
00884450609736	Size (Volume)-3 mL	In distribution
00884450402740	Size (Volume)-20 mL	In distribution
00884450022894	Size (Volume)-6 mL	In distribution
00884450081389	Size (Volume)-60 mL	In distribution
00884450610206	Size (Volume)-30 mL	In distribution
00884450023723	Size (Volume)-6 mL	In distribution
00884450609675	Size (Volume)-1 mL	In distribution
00884450609880	Size (Volume)-6 mL	In distribution
00884450099162	Size (Volume)-10 mL	In distribution
00884450006764	Size (Volume)-20 mL	In distribution
00884450402221		In distribution
00884450402559	Size (Volume)-10 mL	In distribution
00884450120897	Size (Volume)-20 mL	In distribution
00884450120927	Size (Volume)-10 mL	In distribution
00884450402207		In distribution
00884450007068	Size (Volume)-3 mL	In distribution
00884450402764		In distribution
00884450610367	Size (Volume)-10 mL	In distribution
00884450024348	Plunger Color-Light Blue	In distribution
00884450114421	Size (Volume)-20 mL	In distribution
00884450030400	Size (Volume)-10 mL; Plunger Color-Yellow; Size (Volume)-10 mL	In distribution
00884450610398	Size (Volume)-10 mL	In distribution
00884450007082	Size (Volume)-6 mL	In distribution
00884450025802	Size (Volume)-10 mL; Plunger Color-Red; Size (Volume)-10 mL	In distribution
00884450022900	Size (Volume)-30 mL	In distribution
00884450609774	Size (Volume)-3 mL	In distribution
00884450402863		In distribution
00884450402504	Size (Volume)-10 mL	In distribution
00884450006795	Size (Volume)-20 mL	In distribution
00884450021729	Size (Volume)-10 mL; Plunger Color-Light Blue; Size (Volume)-10 mL	In distribution
00884450054420	Size (Volume)-20 mL; Plunger Color-Red; Size (Volume)-20 mL	In distribution
00884450006603	Plunger Color-Yellow; Size (Volume)-10 mL; Plunger Color-Yellow	In distribution
00884450610138	Size (Volume)-20 mL	In distribution
00884450054406	Plunger Color-Light Blue	In distribution
00884450085738	Size (Volume)-3 mL	In distribution
00884450117040	Size (Volume)-20 mL	In distribution
00884450610435	Size (Volume)-20 mL	In distribution
00884450402672		In distribution
00884450401866		In distribution
00884450402436	Size (Volume)-10 mL	In distribution
00884450543931		In distribution
00884450023730	Size (Volume)-30 mL	In distribution
00884450610343	Size (Volume)-10 mL	In distribution
00884450402856		In distribution
00884450046296	Plunger Color-Red	In distribution
00884450402696	Size (Volume)-10 mL	In distribution
00884450120408	Size (Volume)-10 mL	In distribution
00884450610442	Size (Volume)-20 mL	In distribution
00884450053942	Size (Volume)-3 mL	In distribution
00884450006757	Size (Volume)-20 mL	In distribution
00884450609873	Size (Volume)-6 mL	In distribution
00884450104422	Size (Volume)-10 mL; Plunger Color-Light Blue; Size (Volume)-10 mL	In distribution
00884450610060	Size (Volume)-20 mL	In distribution
00884450402788	Size (Volume)-20 mL	In distribution
00884450402825		In distribution
00884450007372	Size (Volume)-3 mL	In distribution
00884450402184		In distribution
00884450401910		In distribution
00884450610121	Size (Volume)-20 mL	In distribution
00884450401873		In distribution
00884450021767	Size (Volume)-10 mL; Plunger Color-Yellow; Size (Volume)-10 mL	In distribution
00884450021705	Plunger Color-Light Blue; Size (Volume)-10 mL; Plunger Color-Light Blue	In distribution
00884450121511	Size (Volume)-10 mL	In distribution
00884450021781	Plunger Color-Red; Size (Volume)-10 mL; Plunger Color-Red	In distribution
00884450076477	Size (Volume)-60 mL	In distribution
00884450609811	Size (Volume)-3 mL	In distribution
00884450023709	Size (Volume)-1 mL	In distribution
00884450402894		In distribution
00884450402191		In distribution
00884450609798	Size (Volume)-3 mL	In distribution
00884450146279	Size (Volume)-20 mL; Plunger Color-Yellow; Size (Volume)-20 mL	In distribution
00884450402702	Size (Volume)-10 mL	In distribution
00884450101995	Size (Volume)-10 mL	In distribution
00884450402870		In distribution
00884450610473	Size (Volume)-20 mL	In distribution
00884450543948		In distribution
00884450013809	Size (Volume)-3 mL	In distribution
00884450610152	Size (Volume)-20 mL	In distribution
00884450006788	Size (Volume)-20 mL	In distribution
00884450023747	Size (Volume)-30 mL	In distribution
00884450610107	Size (Volume)-20 mL	In distribution
00884450402092		In distribution
00884450610381	Size (Volume)-10 mL	In distribution
00884450011300	Size (Volume)-1 mL	In distribution
00884450029282	Plunger Color-White; Size (Volume)-10 mL; Plunger Color-White	In distribution
00884450022801	Plunger Color-Yellow; Size (Volume)-10 mL; Plunger Color-Yellow	In distribution
00884450401897		In distribution
00884450402689	Size (Volume)-10 mL	In distribution
00884450022870	Size (Volume)-1 mL	In distribution
00884450052235	Size (Volume)-20 mL	In distribution
00884450610305	Size (Volume)-6 mL	In distribution
00884450609927	Size (Volume)-6 mL	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Yeso med	Wuxi Yushou Medical Appliances Co., Ltd.	228
Merit Medical®	Merit Medical Systems, Inc.	192
Monoject	Cardinal Health	188
Medline	Medline Industries, Inc.	127
EasyTouch	MHC Medical Products	122
Medline Industries, Inc.	Medline Industries, Inc.	99
Arrow	Teleflex Medical LLC	94
Ceros	Rhino Medical Supply Inc	92
Enteral Feeding	Medela LLC	87
Monoject	Cardinal Health 200, LLC	83
HSW Soft-Ject®	Henke-Sass Wolf, Gmbh.	80
Integra®	Integra Pain Management	77

Showing 12 of 913. All products under Syringe, Piston

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K250853	2025-11-04
K182216	2018-11-06
K182279	2018-11-06
K173601	2018-01-31
K171362	2017-08-07
K152783	2015-12-07
K142636	2014-10-17
K111091	2011-06-24
K024052	2003-02-21
K994253	2000-01-05

Recalls

3 of these are 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
2018-02-02	Class II	Nonconforming Material/Component	Supplier manufacturing defect with the syringe plunger tip.	22,234	2020-11-30
2017-03-23	Class II	Nonconforming Material/Component	Merit Medical Systems announces a voluntary field action for the 1mL Medallion Syringes due to a defect with the syringe plunger tip.	23,032 units	2017-09-26
2014-03-13	Class II	Release of Material/Component prior to receiving test results	The products are labeled as sterile but were not sterilized.	15	2014-07-07
2010-10-22	Not classified	Packaging process control	Packaging for syringes may have holes which would compromise the sterility of the package contents.	49 units	2011-01-18
2010-10-22	Not classified	Packaging process control	Packaging for syringes may have holes which would compromise the sterility of the package contents.	97 units	2011-01-18
2010-10-22	Not classified	Packaging process control	Packaging for syringes may have holes which would compromise the sterility of the package contents.	25 units	2011-01-18
2010-10-22	Not classified	Packaging process control	Packaging for syringes may have holes which would compromise the sterility of the package contents.	789 units	2011-01-18
2010-09-09	Not classified	Employee error	Small holes in the packaging may render the product non-sterile.	10,000 units	2011-03-21
2010-09-09	Not classified	Employee error	Small holes in the packaging may render the product non-sterile.	2337 units	2011-03-21
2010-09-09	Not classified	Employee error	Small holes in the packaging may render the product non-sterile.	199 units	2011-03-21
2010-09-09	Not classified	Employee error	Small holes in the packaging may render the product non-sterile.	746 units	2011-03-21
2010-09-09	Not classified	Employee error	Small holes in the packaging may render the product non-sterile.	2993 units	2011-03-21
2010-09-09	Not classified	Employee error	Small holes in the packaging may render the product non-sterile.	299 units	2011-03-21
2009-09-29	Not classified	Other	Potential sterility breach caused by excessive shipment damage.	25 syringes	2009-12-15
2008-07-09	Not classified	Process control	Control Syringes may be non-sterile due to holes in the packaging.	100 units	2008-11-03
2008-07-09	Not classified	Process control	Control Syringes may be non-sterile due to holes in the packaging.	679 units	2008-11-03
2008-07-09	Not classified	Process control	Control Syringes may be non-sterile due to holes in the packaging.	519 units	2008-11-03
2004-09-14	Not classified	Other	Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.	25 syringes	2005-03-31
2003-10-01	Not classified	Other	There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated t	287 units	2004-02-02
2003-05-16	Not classified	Other	Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.	7257 units	2003-07-21

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.