Who else makes this device?

Name: O-Two
Brand: O-Two

Clinical Chemistry › Laboratory InstrumentsTimer, General Laboratory

O-Two

The Child Ventilation Timer is intended to guide the rescuer to provide ventilation at a rate appropriate for child patients. The green LED light on the 01BM1500 is powered by a 3.0V coin…

Registry build 21.09.26

The Child Ventilation Timer is intended to guide the rescuer to provide ventilation at a rate appropriate for child patients. The green LED light on the 01BM1500 is powered by a 3.0V coin battery to provide a 20 BPM flashing rate (1.0 sec ON and 2.0 sec OFF)

5manufacturers in China registered for this device type

2catalogue numbers in this listing

1recall

Who Else Makes It

Concentrated in Jiangsu (2), Zhejiang (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JBS
Manufacturer	City	Province	Registered as	Device types
Ningbo Ningyuan Import & Export Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	80
Hospital & Homecare IMP. & EXP. Co., Ltd.	Nanjing	Jiangsu	Contract manufacturer	179
Ningbo Castle Medical Import & Export Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	67
Diatrust Medical Co., Ltd.	Nanjing	Jiangsu	Manufacturer	48
Qingdao Unison Industries Co., Limited	Shandong	Shandong	Specification developer	3

Record

Regulatory record for O-Two
Listed by	O-TWO Medical Technologies, Inc., Canada
FDA product code	JBS
Device type	Timer, General Laboratory
Device class	Class 1
Regulation	21 CFR 862.2050
Establishment	Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2019-05-03

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature -20 to 50 °C
Packaging	Pack of 50
Sizes	Circumference 94 mm; weight 3.6 g

Catalogue Numbers

Catalogue numbers for O-Two
Catalogue number	Size	Status
01BM1000	Circumference 94 mm	In distribution
01BM1500	Weight 3.6 g	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Collins Sports Medicine	ASP Global, LLC	1

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2015-06-23	Class II	Mixed-up of materials/components	Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.	4382 units (4082 units distributed USA)	2017-09-01

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.