Who else makes this device?

Name: Trudell
Brand: Trudell

Trudell · Set, Administration, Intravascular → General Hospital

49manufacturers in China registered for this device type

2catalogue numbers in this listing

5510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Zhejiang (12), Jiangsu (11), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FPA
Manufacturer	City	Province	Registered as	Device types
Promisemed Hangzhou Meditech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	21
Hantech Medical Device Co., Ltd.	Cixi	Zhejiang	Contract manufacturer	18
Forefront Medical Technology (Jiangsu) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	14
BQ Plus Medical Co., Ltd.	Songjiang	Shanghai	Contract manufacturer	13
Ningbo Tianyi Medical Appliance Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	11
Anhui Tiankang Medical Technology Co., Ltd.	Tianchang	Anhui	Contract manufacturer	9
Anhui Kangda Medical Products Co., Ltd.	Tianchang	Anhui	Contract manufacturer	7
JDI Electronics Factory	Dongguan	Guangdong	Contract manufacturer	7
Yangzhou Xingwei Medical Technology Co., Ltd.	Yangzhou	Jiangsu	Contract manufacturer	5
Wenzhou K.L.F. Medical Plastics Co., Ltd.	Wenzhou	Zhejiang	Contract manufacturer	4
Advance Technology Ltd	Shenzhen	Guangdong	Contract manufacturer	3
Weihai Jierui Medical Products Co., Ltd.	Weihai	Shandong	Contract manufacturer	3

Showing 12 of 49. All 49 manufacturers in China registered for Set, Administration, Intravascular

Record

Regulatory record for Trudell
Listed by	Codan US Corp., United States
FDA product code	FPA
Device type	Set, Administration, Intravascular
Device class	Class 2
Regulation	21 CFR 880.5440
Establishment	Contract manufacturer, Remanufacturer, Manufacturer
Record published	2020-10-31
Record revised	2024-10-03 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Trudell
Catalogue number	Size	Status
BC 632		In distribution
BC 635		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ICU Medical	ICU Medical, Inc	529
Codan	Codan US Corp.	510
Vygon	Vygon Corp.	355
Port Access Needle	Bard Access Systems, Inc.	341
Set, Administration, Intravascular	Mps Medical, Inc.	291
Alaris, SmartSite	BD Switzerland Sàrl	266
IV Administration Set	B. Braun Medical Inc.	242
Medex	ICU Medical, Inc	237
Extension Set	B. Braun Medical Inc.	171
MaxGuard	BD Switzerland Sàrl	150
Medline	Medline Industries, Inc.	148
Centurion	Centurion Medical Products Corporation	145

Showing 12 of 768. All products under Set, Administration, Intravascular

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K042693	2004-10-21
K033301	2004-03-04
K021480	2002-06-27
K013714	2002-03-28
K001872	2000-09-07

Recalls

2 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
2019-09-12	Class II	Packaging process control	Individual packages of connectors may have incomplete or bad seals which would compromise sterility.	34,776 units	2021-04-28
2011-08-17	Class II	Other	CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.	7250 units	2014-07-10

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.

Trudell