Rescuer Emergency CPAP System - Rescuer Emergency CPAP System is a disposable - B.L.S. Systems Limited

Duns Number:200103823

Device Description: Rescuer Emergency CPAP System is a disposable CPAP generator with CPAP mask and pre-attach Rescuer Emergency CPAP System is a disposable CPAP generator with CPAP mask and pre-attached bonnet headgear for the purpose of generating and maintaining continuous positive airway pressure (CPAP) to a patient exhibiting signs and symptoms or respiratory distress.

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More Product Details

Catalog Number

8700

Brand Name

Rescuer Emergency CPAP System

Version/Model Number

8700

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122610,K122610

Product Code Details

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Device Record Status

Public Device Record Key

06f1836e-a9b9-479e-95f2-67fd0219f6c8

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

May 05, 2015

Additional Identifiers

Package DI Number

B00287001

Quantity per Package

6

Contains DI Package

B00287000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case of 6

"B.L.S. SYSTEMS LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 32