IOB-009/IOB-009S Large Pediatric Under Body Warming Blanket

Registration Details

Registration Name: Jiangmen Dacheng Medical Equipment Co., Ltd.
Registration Number: 3010168054
FEI Number: 3010168054
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: #8 South of Jiaobei Hengkeng, Jianghai District
City: Jiangmen Guangdong
Country: CN

Regulatory Submissions

510(k) Number: K231596

Owner / Operator

Firm Name: Gentherm Medical LLC
Operator Number: 10042384
Address: 12011 Mosteller Road
City: Cincinnati
State: OH
Postal Code: 45241
Country: US
Correspondent: Jonathan Kovach

US Agent

Business Name: Gentherm Medical LLC
Contact Name: Jonathan Kovach
Address: 12011 Mosteller Road
City: Cincinnati
State: OH
ZIP: 45241
Country: US
Email: [email protected]
Phone: 513 3265295

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
System, Thermal Regulating	DWJ	Class 2	Cardiovascular	No	2023-07-03

Proprietary Names

IOB-009/IOB-009S Large Pediatric Under Body Warming Blanket IOB-034/IOB-034S Arms-in Upper Body Warming Blanket IOB-304/IOB-304S Extra Large Size Warming Suit IOB-007/IOB-007S Pediatric Full Body Warming Blanket IOB-029/IOB-029S Lithotomy & Orthopedic Under Body Warming Blanket IOB-010/IOB-010S Spinal Under Body Warming Blanket IOB-012/IOB-012S Pediatric Lower Body Warming Blanket IOB-301/IOB-301S Small Size Warming Suit IOB-006/IOB-006S Adult Under Body Warming Blanket IOB-004/IOB-004S Full Body Warming Blanket IOB-022/IOB-022S Outpatient Care Warming Blanket IOB-016/IOB-016S Surgical Access Warming Blanket IOB-303/IOB-303S Large Size Warming Suit IOB-027/IOB-027S Large Full Body Warming Blanket IOB-003/IOB-003S Upper Body Warming Blanket IOB-011/IOB-011S Lithotomy Under Body Warming Blanket IOB Temperature Management System Model IOB-507 IOB-017/IOB-017S Chest Access Warming Blanket IOB-026/IOB-026S Large Half Body Warming Blanket KoZee Full Access Under Body Warming Blanket, M21006 IOB-005/IOB-005S Pediatric Under Body Warming Blanket IOB-014/IOB-014S Pediatric Long Warming Blanket KoZee Warming Unit M21507 KoZee Full Body Warming Blanket Postoperative, M21007 KoZee Large Warming Suit, M21303 KoZee Cardiac Access Warming Blanket Other, M21020 KoZee Lower Body Warming Blanket Pediatric, M21012 KoZee Medium Warming Suit, M21302 IOB-302/IOB-302S Medium Size Warming Suit IOB-030/IOB-030S Multi-position Upper Body Warming Blanket IOB-019/IOB-019S Dual Port Torso Warming Blanket KoZee Small Warming Suit, M21301 IOB-025/IOB-025S Infant Full Body & Under Body Warming Blanket KoZee Infant Under Body Warming Blanket, M21028 IOB-001/IOB-001S Torso Warming Blanket IOB-015/IOB-015S Cath Lab Warming Blanket KoZee Lower Body Warming Blanket Intraoperative, M21002 KoZee Full Body Surgical Warming Blanket Postoperative, M21008 KoZee Extra Large Warming Suit, M21304 KoZee Adult Full Body Warming Blanket Postoperative, M21004 IOB-002/IOB-002S Lower Body Warming Blanket IOB-020/IOB-020S Cardiac Access Warming Blanket KoZee Multi-Position Upper Body Blanket, M21030 KoZee Upper Body Blanket, M21003 KoZee Infant Full Body & Upper Body Warming Blanket, M21025 KoZee Large Under Body Warming Blanket, M21009 IOB-021/IOB-021S XL Upper Body Warming Blanket IOB-023/IOB-023S Cardiac Warming Blanket IOB-028/IOB-028S Infant Under Body Warming Blanket IOB-008/IOB-008S Full Body Surgical Warming Blanket IOB-018/IOB-018S Multi-Access Warming Blanket IOB-024/IOB-024S Jackson Warming Blanket KoZee Cath Lab Warming Blanket Other, M21015 KoZee Surgical Access Warming Blanket Other, M21016 KoZee XL Upper Body Warming Blanket Intraoperative, M21021 KoZee Under Body Warming Blanket, M21005 KoZee Spinal Under Body Warming Blanket, M21010 KoZee Torso Warming Blanket Intraoperative, M21001 KoZee Lithotomy&Orthopedic Under Body Warming Blanket, M21029 KoZee Long Warming Blanket Pediatric, M21014

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)