o_two CPAP 01CV0218-CS

GUDID 17540195035079

The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients. The adjustment of the CPAP level is achieved by adjust

O-Two Medical Technologies Inc

CPAP/BPAP face mask, single-use
Primary Device ID17540195035079
NIH Device Record Key1b8b9e30-3f2c-4b19-bdda-70dd78eb0946
Commercial Distribution StatusIn Commercial Distribution
Brand Nameo_two CPAP
Version Model Number01CV0218
Catalog Number01CV0218-CS
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Weight0.1 Kilogram

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195035072 [Primary]
GS117540195035079 [Package]
Contains: 07540195035072
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYEAttachment, Breathing, Positive End Expiratory Pressure

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 Date2015-10-24

On-Brand Devices [o_two CPAP]

17540195035147The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
17540195035130The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
07540195035126The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
17540195035116The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
17540195035109The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
17540195035093The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
17540195035086The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
17540195035079The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
17540195035062The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
07540195035058The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
17540195035048The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
17540195035031The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
17540195035024The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.

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