EsoCool

EsoCool Esophageal Cooling Catheter, 40 cm

Registry build 21.09.26
33manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (11), Guangdong (7), Zhejiang (6). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KMJ
Manufacturer City Province Registered as Device types
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Primecare Medical (Huzhou) Co., Ltd. Hu Zhou Zhejiang Contract manufacturer 9
Nantong Health & Beyond Hygienic Products Inc. Rugao Jiangsu Contract manufacturer 2
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Yiwu Ori-Power Medtech Co., Ltd. Yiwu Zhejiang Contract manufacturer 46
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Xiamen Firstcare IMP. & EXP. Co., Ltd. Xiamen Fujian Exporter 40
Emsrun Group Wuxi Jiangsu Specification developer 34
Hangzhou Primecare Medical Co., Ltd. Hangzhou Zhejiang Contract manufacturer 29

Showing 12 of 33. All 33 manufacturers in China registered for Lubricant, Patient

Record

Regulatory record for EsoCool
Listed by Nuvaira, Inc., United States
FDA product code KMJ
Device type Lubricant, Patient
Device class Class 1
Regulation 21 CFR 880.6375
Record published 2025-01-29
Record revised 2026-05-15 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Sizes Catheter working length 40 cm
Distribution end date 2025-12-31

Catalogue Numbers

Catalogue numbers for EsoCool
Catalogue number Size Status
ESC-40 Catheter Working Length 40 cm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgilube HR Pharmaceuticals Inc. 8
HR Lubricating Jelly HR Pharmaceuticals Inc. 8
EndoGlide+™ Jianerkang Medical Co., Ltd. 8
HCS Dyad Medical Sourcing, LLC 7
Cardinal Health Cardinal Health 200, LLC 6
Curaplex Bound Tree Medical, LLC 6
Aquagel Parker Laboratories, Inc. 5
Dukal Dukal LLC 5
Regard™ Resource Optimization & Innovation, L.L.C. 5
EZ Lubricating HR Pharmaceuticals Inc. 4
PremierPro Prestige Ameritech 4
Medline Medline Industries, Inc. 4

Showing 12 of 53. All products under Lubricant, Patient

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.

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