What is FDA product code OVR?

The device provides verbal instructions pertaining to various first aid and common medical emergencies. The device does not contain any drug or supporting device that could be applied to the patient.

General & Plastic Surgery › SurgicalKit, First Aid, Talking

PRO1TEK Trauma First Aid Advanced Kit- 1+ Patient

Name: PRO1TEK Trauma First Aid Advanced Kit- 1+ Patient
Brand: PRO1TEK Trauma First Aid Advanced Kit- 1+ Patient

PRO1TEK Medical Trauma First Aid Advanced Bleeding Kit- 1 + Patient with Hemostatic Dressing and other Bleeding Control Aids

Registry build 21.09.26

18manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (5), Zhejiang (5), Henan (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OVR
Manufacturer	City	Province	Registered as	Device types
Hangzhou Rollmed Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	127
Jiangsu Saikang Medical Equipment Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	34
Wenzhou Caretek Medical Device Co., Ltd.	Wenzhou	Zhejiang	Contract manufacturer	30
Hospital & Homecare IMP. & EXP. Co., Ltd.	Nanjing	Jiangsu	Contract manufacturer	179
Hynaut Health Technology Co., Ltd.	Qingdao	Shandong	Contract manufacturer	68
Yiwu Ori-Power Medtech Co., Ltd.	Yiwu	Zhejiang	Contract manufacturer	46
Henan Yadu Industrial Co., Ltd.	Changyuan	Henan	Contract manufacturer	35
Jiangsu Yongfa Medical Equipment Technology Co., Ltd.	Zhangjiagang	Jiangsu	Manufacturer	33
Shanghai NO. 2 Medical College Duhang Medical Equipment Factory	Shanghai	Shanghai	Contract manufacturer	32
Yadu Medical (Henan) Co., Ltd.	Changyuan	Henan	Contract manufacturer	30
Amis (Xiamen) Cultural Creativity Co., Ltd.	Xiamen	Fujian	Manufacturer	28
Jiangsu Hongsheng Bioengineering Co., Ltd.	Nantong	Jiangsu	Manufacturer	28

Showing 12 of 18. All 18 manufacturers in China registered for Kit, First Aid, Talking

Record

Regulatory record for PRO1TEK Trauma First Aid Advanced Kit- 1+ Patient
Listed by	Pro1tek
FDA product code	OVR
Device type	Kit, First Aid, Talking
Device class	Class 1
Regulation	21 CFR 878.4014
Record published	2022-05-03

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for PRO1TEK Trauma First Aid Advanced Kit- 1+ Patient
Catalogue number	Size	Status
B283E1SBDPDBP0		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
PRO1TEK Trauma First Aid Advanced Bleeding Control Kit- 2+ Patient Ifak w/BC	Pro1tek	5
Empact Active Shooter Tool Kit- Advanced Bleeding Control Kit- 10+ Patient	Pro1tek	5
Emergency Medical Products	Emergency Medical Products, Inc.	4
Mobilize	Zoll Medical Corporation	4
Empact 6+ Patient Hard Case Kit with Wall Cabinet OTC	Pro1tek	2
PRO1TEK Ifak EMT BAG	Pro1tek	1
PRO1TEK Trauma First Aid Advanced Ifak Kit	Pro1tek	1
Empact 6+ Patient Hard Case Trauma Kit- Bat Flashlight RX	Pro1tek	1
PRO1TEK Trauma First Aid Bleeding Control Kit – Vehicle Kit	Pro1tek	1
PRO1TEK 2+ Patient Ifak Kit	Pro1tek	1
PRO1TEK Ifak EMT CCR Leg RIG BAG	Pro1tek	1
Empact Active Shooter Tool Kit – 6+ Patient Advanced Bleeding Control Kit	Pro1tek	1

Showing 12 of 20. All products under Kit, First Aid, Talking

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.