CAREvent ALS+ 01CV4000

GUDID 07540195025295

CAREvent ALS+ is intended to provide artificial ventilation for patients during respiratory and cardiac arrest. The single control for the simultaneou

O-Two Medical Technologies Inc

Pulmonary resuscitator, pneumatic, reusable
Primary Device ID07540195025295
NIH Device Record Key2391bc0f-c514-4d4b-bd9e-6be4069865f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAREvent ALS+
Version Model Number01CV4000
Catalog Number01CV4000
Company DUNS206449154
Company NameO-Two Medical Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-387-3405
Emailcs@otwo.com

Device Dimensions

Weight1.5 Kilogram
Height2.95 Inch
Width5.5 Inch
Length8.1 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195025295 [Direct Marking]
GS107540195025301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTLVentilator, Emergency, Powered (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-26

Devices Manufactured by O-Two Medical Technologies Inc

07540195020269 - O Two 2024-05-07 Demand Valve Resuscitator- FERNO O-Two Demand Valve Resuscitator comes standard with pressure relief system and audible alarm a
17540195040073 - Pro Nox2023-11-21 The PRO NOX Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device de
07540195015012 - O-Two 2023-11-15 Nitrile Powder Free Gloves
07540195015029 - O-Two 2023-11-15 Supply Hose Assembly
07540195015036 - O-Two 2023-11-15 Supply Hose Assembly
07540195050051 - O-Two 2023-11-15 The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice, non-gravity sensitive flow cont
07540195050075 - O-Two 2023-11-15 FLOW CONTROL 0-25 LPM O2 DISS. The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice,
17540195035154 - O-Two 2023-06-30 O-Two Single-Use CPAP Nebulizer System c/w 6 L/min Flow Adapter, T-Piece, Updraft Nebulizer with Oxygen Supply Tubing

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.