O-wo Demand Valve

FDA UDI

Class II (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name: O-wo Demand Valve FDA UDI
Generic Name: Demand valve FDA UDI
Device Name: O-Two Demand Valve Resuscitator comes standard with pressure relief system and audible alarm as well a manual ventilation button conveniently located on the front of the resuscitator. The manual ventilation flow rate is fixed at 40 L/min. During spontaneous respirations, the Demand valve resuscitator is designed to provide 100% oxygen to the patient with minimal inspiratory effort. The oxygen demand flow is controlled by the patient’s inspiratory effort with a minimum peak flow rate of 140 L/min to accommodate the patient’s own respiratory distress situation. FDA UDI
Model / Reference: 01DV2000 FDA UDI
Description: O-Two Demand Valve Resuscitator comes standard with pressure relief system and audible alarm as well a manual ventilation button conveniently located on the front of the resuscitator. The manual ventilation flow rate is fixed at 40 L/min. During spontaneous respirations, the Demand valve resuscitator is designed to provide 100% oxygen to the patient with minimal inspiratory effort. The oxygen demand flow is controlled by the patient’s inspiratory effort with a minimum peak flow rate of 140 L/min to accommodate the patient’s own respiratory distress situation. FDA UDI

Identifiers

Catalog Number: 01DV2000 FDA UDI
Primary DI / UDI-DI: 07540195020023 FDA UDI
510(k) Number: K922810 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Demand valve FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5915 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 0.23 Kilogram FDA UDI
Height — 3.5 Inch FDA UDI
Outer Diameter — 2.0 Inch FDA UDI

Category: Demand valve

O-wo Demand Valve by O-Two Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Demand valve.

Life Support Products — Allied Medical LLC · Class II
Suction Cup, ACD-CPR Device — Zoll Medical Corporation · Class III
Allied Medical LLC — Allied Medical LLC · Class II
Life Support Products — Allied Medical LLC · Class II
Life Support Products (LSP) — Allied Medical LLC · Class II
Life Support Products — Allied Medical LLC · Class II
Life Support Products — Allied Medical LLC · Class II
BPR Medical — Bpr Medical, Ltd. · Class II

Cleared under the same submission

K922810 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: O-Two Medical Technologies Inc

Sources (1)

FDA UDI a0d36d40-f170-4369-9ea0-119f65ffbde0 38 fields · synced Jun 8, 2026