Probe, Thermodilution

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Jiangsu and Shandong: 3 hold an FDA registration. 2 are contract manufacturers.

Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
Bioxin Medical Co., Ltd. Shandong, contract manufacturer
GE Medical Systems (China) Co., Ltd. Jiangsu, contract manufacturer

What Is FDA Product Code KRB?

Probe, Thermodilution is FDA product code KRB, Class 2, 21 CFR 870.1915.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 4 recalls under this product code since 2014. None was by a company in China. The root causes the FDA records most often are Equipment maintenance (3) and Packaging (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Probe, Thermodilution

Criticath(TM) SP5127H TD Catheter

Heparin coated Catheter of 7FR, 4 Lumen with length 110cm

Probe, Thermodilution

Criticath SP5107-13 TD Catheter

Catheter with 7FR, 4Lumen, length 110cm

Probe, Thermodilution

1-FEMORAL Catheter KIT (5f, 20 CM), Single Pack

VolumeView

Probe, Thermodilution

ITS Housing

Catalogue number PV4046, listed by Maquet Critical Care AB, Sweden, under Probe, Thermodilution. 3 manufacturers in China are registered for this product code.

Probe, Thermodilution

Criticath(TM) SP5507H-14 TD Catheter

Heparin coated catheter 7.5Fr, 5 Lumen with length 110cm

Probe, Thermodilution

Criticath(TM) SP5527H TD Catheter

Heparin coated catheter, 7.5Fr, 5 Lumen with length 110cm

Probe, Thermodilution

Criticath™ SP5107H + SP5045 TD Catheter

Heparin coated catheter, 7Fr, 4 Lumen with tube length 110 cm

Probe, Thermodilution

Criticath(TM) SP5507HS TD Catheter

Heparin coated Catheter of 7.5FR, 5 Lumen, Length 110cm

Probe, Thermodilution

Criticath™ SP5507H TD Catheter

Heparin Coated Catheter, 7.5Fr, 5 Lumen and tube length 110cm

Probe, Thermodilution

Criticath(TM) SP5107H-13 TD Catheter

Heaprin coated catheter 7FR, 4Lumen with length 110cm

Probe, Thermodilution

Criticath SP5107-14 TD Catheter

Catheter 7FR, 4 Lumen, 110cm

Probe, Thermodilution

Criticath™ SP5107H TD Catheter

Heparin coated catheter, 7Fr, 4 Lumen with length 110cm

Probe, Thermodilution

Criticath SP5507S TD Catheter

Catheter 7.5 FR, 5 Lumen, length 110cm

Probe, Thermodilution

Criticath(TM) SP5107 TD Catheter

Catheter with 7FR, 4 lumen & length 110cm

Probe, Thermodilution

Criticath SP5107S TD Catheter

Catheter with 7FR, 4 Lumen, length 110 cm

Probe, Thermodilution

Critikit(TM) SP4572

Injectate delivery system includes a sensor housing with two-way check valve, a cooling coil, a IV administration set, a 10 cc control syringe, 3-way stopcock and two male luer lock…

Probe, Thermodilution

Criticath(TM) SP5537H Pacing Catheter

Heparin coated Catheter 7.5 FR, 5 Lumen with length 110 cm

Probe, Thermodilution

Criticath(TM) SP5107HS TD Catheter

Heparin coated catheter of 7Fr, 4 Lumen, length 110cm

Probe, Thermodilution

Carescape

Carescape D19KT VER01

Probe, Thermodilution

Criticath SP5507-14 TD Catheter

Catheter 7.5FR, 5Lumen length 110cm

Probe, Thermodilution

Criticath(TM) SP5537H-13 Pacing Catheter

Heparin coated Catheter7.5FR, 5 Lumen with length 110 cm

Probe, Thermodilution

SP5555-POLE Mounting Bracket

Catalogue number 682161, listed by Argon Critical Care Systems Singapore PTE. Ltd., under Probe, Thermodilution. 3 manufacturers in China are registered for this product code.

Probe, Thermodilution

Criticath(TM) SP5107H TD Catheter

Heparin coated catheter with 7Fr, 4 Lumen, length 110cm

Probe, Thermodilution

Criticath(TM) SP5107H-14 TD Catheter

Heparin coated Catheter 7FR, 4Lumen with length 110cm

Probe, Thermodilution

Criticath(TM) SP5105H TD Catheter

Heparin coated catheter 5FR,4Lumen, length 80 cm

Probe, Thermodilution

PiCCO Monitoring Kit

3 catalogue numbers from PV8103, listed by Pulsion Medical Systems SE, Germany, under Probe, Thermodilution. 3 manufacturers in China are registered for this product code.

Probe, Thermodilution

Co-SET+

Co-SET(R) AND Syringe F/USE W/ 93-500,-510,-600,-610 5EA/CA

Probe, Thermodilution

Criticath(TM) SP5507H-13 TD Catheter

Heparin coated Catheter with 7.5FR, 5 Lumen, Length 110 cm

Probe, Thermodilution

Criticath(TM) SP5105H-14 TD Catheter

Heparin coated catheter of 5Fr, 4Lumen and length 80cm

Probe, Thermodilution

Star 65

Multi-Parameter Patient Monitoring System

Probe, Thermodilution

Criticath(TM) SP5507H TD Catheter

Heparin coated Catheter 7.5FR,5 Lumen with length 110cm

Probe, Thermodilution

Safewedge(TM) Relief Valve Device

Catalogue number Safetywedge, listed by Bioptimal International Pte. Ltd., Singapore, under Probe, Thermodilution. 3 manufacturers in China are registered for this product code.

Probe, Thermodilution

Co-SET Injectate ICE Bucket

Co-SET Injectate ICE Bucket 6 PER Case

Probe, Thermodilution

Critikit(TM) SP4500

CRITIKIT(TM) SP4500 consists of a banded cooling coil connected via a 40" pressure tubing and a 2-way check valve. It has a 10ml control syringe and a separate packed 3-way stopcock and 2…

Probe, Thermodilution

PiCCO Catheter

5 catalogue numbers from PV2014L08, listed by Maquet Critical Care AB, Sweden, under Probe, Thermodilution. 3 manufacturers in China are registered for this product code.

Probe, Thermodilution

Criticath™ SP5107H-14 TD Catheter

Heparin coated catheter 7 Fr, 4 Lumen with tube 110cm

Probe, Thermodilution

Injectate Temperature Sensor Housing

Injectate temperature sensor housing PV4046

Probe, Thermodilution

Criticath(TM) SP5537H-14 Pacing Catheter

Heparin coated Catheter7.5 FR, 5 Lumen with length 110cm

Probe, Thermodilution

Single-Patient Finger SpO2sensor Package

Catalogue number 115-002187-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Probe, Thermodilution. 3 manufacturers in China are registered for this product code.

Probe, Thermodilution

Co Upgrd Pkg/no Accssry

Catalogue number 115-047285-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Probe, Thermodilution. 3 manufacturers in China are registered for this product code.

Probe, Thermodilution

Criticath SP5507-13 TD Catheter

Catheter with 7.5FR, 5 Lumen,length 110cm

Probe, Thermodilution

Criticath(TM) SP5507 TD Catheter

Catheter with 7.5FR, 5 Lumen, Tube length 110cm

Probe, Thermodilution

Criticath(TM) SP5507S TD Catheter

Catheter of 7.5FR, 5 Lumen, with length 110cm

Probe, Thermodilution

Co Module W/ Cable & Accessory

Catalogue number 115-047283-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Probe, Thermodilution. 3 manufacturers in China are registered for this product code.

Probe, Thermodilution

Adler Instrument Company

House-Rosen Needle Semi-sharp

Probe, Thermodilution

Criticath(TM) SP5105HL TD Catheter

Heparin coated catheter 5FR, 4 Lumen, length 110cm

Probe, Thermodilution

PiCCO Catheter

5F Thermodilution catheter, 200mm

Probe, Thermodilution

Critikit™

3 catalogue numbers from 10884450320911, listed by Argon Critical Care Systems Singapore PTE. Ltd., under Probe, Thermodilution. 3 manufacturers in China are registered for this product code.

Probe, Thermodilution

ICU Medical

Thermoset™ Room Temperature Closed-Loop Injectable Delivery System with In-Line Temperature Probe

Probe, Thermodilution

VolumeView

1-FEMORAL Catheter KIT (5F, 20 CM), Single Pack

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer