Primary Device ID | 07540195025325 |
NIH Device Record Key | 48cafaa6-1640-4901-858a-ee80b1fc92bd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CAFREvent ALS+ CPAP |
Version Model Number | 01CV4000-CPAP |
Catalog Number | 01CV4000-CPAP |
Company DUNS | 206449154 |
Company Name | O-Two Medical Technologies Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-800-387-3405 |
cs@otwo.com |
Weight | 1.5 Kilogram |
Height | 2.95 Inch |
Width | 5.5 Inch |
Length | 8.1 Inch |
Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07540195025318 [Direct Marking] |
GS1 | 07540195025325 [Primary] |
BTL | Ventilator, Emergency, Powered (Resuscitator) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-10-26 |
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 Nox | 2023-11-21 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 |