Primary Device ID | 07540195025295 |
NIH Device Record Key | 2391bc0f-c514-4d4b-bd9e-6be4069865f8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CAREvent ALS+ |
Version Model Number | 01CV4000 |
Catalog Number | 01CV4000 |
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 | 07540195025295 [Direct Marking] |
GS1 | 07540195025301 [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 |
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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 |