What is FDA product code OHO?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

General & Plastic Surgery › SurgicalFirst Aid Kit Without Drug

SDR Vehicle Kit Refill-OTC

Name: SDR Vehicle Kit Refill-OTC
Brand: SDR Vehicle Kit Refill-OTC

31-115 TMT Tourniquet 1.00EA GLOVES-2.00.101 Synmax, Blue, Industrial Grade, Powered Free, Latex Free 1.00 PR 30-212 MARCH Celox Rapid B-CON 3"x2' OTC 1.00EA 11-100-QR-EN POSTIONAL AIRWAY -…

Registry build 21.09.26

31-115 TMT Tourniquet 1.00EA GLOVES-2.00.101 Synmax, Blue, Industrial Grade, Powered Free, Latex Free 1.00 PR 30-212 MARCH Celox Rapid B-CON 3″x2′ OTC 1.00EA 11-100-QR-EN POSTIONAL AIRWAY – ENGLISH 2.00 1.00EA L-SDR-VSIP-OTC-REFILSDR Vehicle Kit – OTC-Refill Insert 1.00EA 20-001-KOI Sentinel Chest Seal 2.00 1.00EA FCP-01 ETD 1.00EA BPS-47 Blizzard IFAK 1.00EA 95-000-QR-EN MARCH Cover QR Card – English 1.00EA 31-115-QR-EN TMT – ENGLISH 1.00EA 30-212-QR-EN CELOX RAPID B-CON – ENGLISH 1.00EA 20-001-QR-EN SENTINEL CHEST SEAL – ENGLISH 1.00EA 32-150-QR-EN COMPRESSION DRESSING – ENGLISH 1.00EA 04-101-QR-EN EMERGENCY BLANKET – ENGLISH 1.00EA P81-111 Snap Ring, 1/2″ ID, Acetal (.55/13.5mm ID) 1.00EA L01-00 33×1 blank polypropylene TT label 1.00EA P81-250-07 Inner Pouch, PA Kit 7×1 1.00EA P59-100 Inner Pouch, Hypothermia Kit 1.00EA

132manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (46), Jiangsu (35), Guangdong (17). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OHO
Manufacturer	City	Province	Registered as	Device types
Hangzhou Rollmed Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	127
Shanghai Joy Crown Industry Co., Ltd.	Pu Dong New Area	Shanghai	Contract manufacturer	64
Allmed Medical Products Co., Ltd.	Zhijiang	Hubei	Contract manufacturer	43
Shanghai Care Us Medical Product Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	30
Jinhua Jingdi Medical Supplies Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	29
Yiwu Haoding Medical Co., Ltd.	Yiwu	Zhejiang	Contract manufacturer	23
Anji Hengfeng Sanitary Material Co., Ltd.	Anji	Zhejiang	Contract manufacturer	20
Changzhou Recoo Healthcare Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	19
Hangzhou Aosi Healthcare Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	18
Caremax Co., Ltd.	Suzhou, Jiangsu Province		Contract manufacturer	17
Zhejiang Changdi Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	16
Nantong City Yojo Medical Products Co., Ltd.	Haimen	Jiangsu	Contract manufacturer	14

Showing 12 of 132. All 132 manufacturers in China registered for First Aid Kit Without Drug

Record

Regulatory record for SDR Vehicle Kit Refill-OTC
Listed by	Safeguard US Operating, LLC, United States
FDA product code	OHO
Device type	First Aid Kit Without Drug
Device class	Class 1
Regulation	21 CFR 878.4014
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2022-06-07

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Label carries	lot or batch number, manufacturing date
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for SDR Vehicle Kit Refill-OTC
Catalogue number	Size	Status
2		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
NAR	North American Rescue, LLC.	883
Curaplex	Bound Tree Medical, LLC	284
Rhino Rescue	Wuxi Emsrun Technology Co., Ltd.	128
Ifak	Faretec, Inc.	93
Garyline	Garyline LLC	86
First Aid Only	Acme United Corp.	76
Rhino Rescue	Emsrun Group	55
Emsrun	Wuxi Emsrun Technology Co., Ltd.	31
OP – First aid series	Yiwu Ori-Power Medtech Co., Ltd.	23
Tealmed	Ningbo Tealmed Emergency Products Co., Ltd.	13
NAR Kit	North American Rescue, LLC.	11
StBernard	Emsrun Group	10

Showing 12 of 470. All products under First Aid Kit Without Drug

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.