Who else makes this device?

Name: ICU Medical, Inc.
Brand: ICU Medical, Inc.

ICU Medical, Inc. · Port & Catheter, Implanted, Subcutaneous, Intravascular → General Hospital

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LJT
Manufacturer	City	Province	Registered as	Device types
Turnxon Precision Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	17
Forefront Medical Technology (Jiangsu) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	14

Record

Regulatory record for ICU Medical, Inc.
Listed by	ICU Medical, Inc, United States
FDA product code	LJT
Device type	Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class	Class 2
Regulation	21 CFR 880.5965
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K093414
Record published	2026-01-05

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for ICU Medical, Inc.
Catalogue number	Size	Status
21-4437-24		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Dignity®	Medical Components Inc	168
Deltec	ICU Medical, Inc	130
NorPort Vascular Access Port	Norfolk Medical	106
BioFlo Vortex	AngioDynamics, Inc.	60
BioFlo Vortex	Navilyst Medical, Inc.	59
Dignity® MID-Sized CT Port	Medical Components Inc	55
TidalPort Vascular Access Port	Norfolk Medical	52
Pro-Fuse® Low Profile CT Port	Medical Components Inc	45
Dignity® Low Profile CT Port	Medical Components Inc	45
Dignity® Mini CT Port	Medical Components Inc	44
Medcomp GEN III Power Injectable Portmedcomp GEN III Power Injectable Port	Medical Components Inc	29
PRO-Fuse®	Medical Components Inc	28

Showing 12 of 96. All products under Port & Catheter, Implanted, Subcutaneous, Intravascular

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of ICU Medical, Inc.
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Smiths Medical Asd, Inc.	510(k) number	2017-12-04	Class II	Process design	Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also con	1,077 units total	2020-06-12

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.

ICU Medical, Inc.