Rescuer II Compact CPAP System 8810

GUDID B00288101

Rescuer II Compact CPAP System is a more compact version of the Rescuer Emergency CPAP System. This is a disposable CPAP mask (Model 8810 is the small

B.L.S. Systems Limited

CPAP/BPAP face mask, single-use
Primary Device IDB00288101
NIH Device Record Keyd40e1f5b-ff34-4645-9bf5-4b89f0fe5487
Commercial Distribution StatusIn Commercial Distribution
Brand NameRescuer II Compact CPAP System
Version Model Number8810
Catalog Number8810
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 339 1069
Emailtedreesor@blssystemsltd.com
Phone905 339 1069
Emailtedreesor@blssystemsltd.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB00288100 [Primary]
HIBCCB00288101 [Package]
Contains: B00288100
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 II Compact CPAP System]

B00288551Rescuer II Compact CPAP System is a more compact version of the Rescuer Emergency CPAP System. T
B00288501Rescuer II Compact CPAP System is a more compact version of the Rescuer Emergency CPAP System wh
B00288101Rescuer II Compact CPAP System is a more compact version of the Rescuer Emergency CPAP System. T
B00288051The Rescuer II Compact CPAP System is a more compact version of the Rescuer Emergency CPAP Syste
B00288001The Rescuer II Compact CPAP System is a more compact version of the Rescuer Emergency CPAP Syste

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