Who else makes this device?

Name: Shp Unit PiCCO Pod
Brand: Shp Unit PiCCO Pod

Cardiovascular › DiagnosticComputer, Diagnostic, Pre-Programmed, Single-Function

Shp Unit PiCCO Pod

Catalogue number MS17441, listed by Draeger Medical Systems, Inc., United States, under Computer, Diagnostic, Pre-Programmed, Single-Function. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DXG
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57
Orantech Inc.	Shenzhen	Guangdong	Contract manufacturer	40
Shenzhen Comen Medical Instruments Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	24

Record

Regulatory record for Shp Unit PiCCO Pod
Listed by	Draeger Medical Systems, Inc., United States
FDA product code	DXG
Device type	Computer, Diagnostic, Pre-Programmed, Single-Function
Device class	Class 2
Regulation	21 CFR 870.1435
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K073113
Record published	2015-11-02
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date

Catalogue Numbers

Catalogue numbers for Shp Unit PiCCO Pod
Catalogue number	Size	Status
MS17441		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
LiDCO Ltd	Lidco Ltd.	133
LiDCO	Lidco Ltd.	32
Transonic	Transonic Systems, Inc.	31
Computer, Diagnostic, Pre-Programmed, Single-Function	Edwards Lifesciences Technology Sarl	23
Retia Medical	Retia Medical, LLC	17
EV1000	Edwards Lifesciences Technology Sarl	11
Computer, Diagnostic, Pre-Programmed, Single-Function	GE Healthcare Finland OY	5
Pediasat	Edwards Lifesciences Technology Sarl	4
LiDCO	Masimo Corporation	4
ICU Medical	ICU Medical, Inc	4
Cnap® Monitor 500 HD	Cnsystems Medizintechnik GmbH	4
Vigileo	Edwards Lifesciences Technology Sarl	3

Showing 12 of 39. All products under Computer, Diagnostic, Pre-Programmed, Single-Function

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K073113	2008-01-03

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.