Rescuer Emergency CPAP System 8755

GUDID B00287551

Rescuer Emergency CPAP System with #4 Cushion Mask and silicone head strap used for patients exhibiting acute episodes of respiratory distress.

B.L.S. Systems Limited

CPAP/BPAP face mask, single-use
Primary Device IDB00287551
NIH Device Record Key659d901b-b327-4a57-81ab-1e7984ffe247
Commercial Distribution StatusIn Commercial Distribution
Brand NameRescuer Emergency CPAP System
Version Model Number8755
Catalog Number8755
Company DUNS200103823
Company NameB.L.S. Systems Limited
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone905 3391069
Emailtedreesor@blssystemsltd.com
Phone905 3391069
Emailtedreesor@blssystemsltd.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB00287550 [Primary]
HIBCCB00287551 [Package]
Contains: B00287550
Package: Case of 6 [6 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 Number4
Public Version Date2018-07-06
Device Publish Date2015-05-05

On-Brand Devices [Rescuer Emergency CPAP System]

B20087101Rescuer Emergency CPAP Systems with small CPAP mask and pre-attached bonnet is a single patient
B00287551Rescuer Emergency CPAP System with #4 Cushion Mask and silicone head strap used for patients exh
B20087501Rescuer Emergency CPAP System with #6 cushion mask and silicone head strap used to deliver conti
B00287050Rescuer Emergency CPAP System with Medium sized CPAP mask and pre-attached bonnet used for acute
B00287001Rescuer Emergency CPAP System is a disposable CPAP generator with CPAP mask and pre-attached bon

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