Rescuer II Compact CPAP System with Small Deluxe C 8810-NK

GUDID B0028810NK1

Rescuer II Compact CPAP System with Small Deluxe CPAP Mask and Nebulizer Kit

B.L.S. Systems Limited

In-line CPAP set, nebulizing
Primary Device IDB0028810NK1
NIH Device Record Key889eea6a-7cc5-4b1b-9449-61cf781d6a8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameRescuer II Compact CPAP System with Small Deluxe C
Version Model Number8810-NK
Catalog Number8810-NK
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

Phone9053391069
Emailtedreesor@blssystemsltd.com
Phone9053391069
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
HIBCCB0028810NK0 [Primary]
HIBCCB0028810NK1 [Package]
Contains: B0028810NK0
Package: Case [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-02
Device Publish Date2018-10-02

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