Rescuer Emergency CPAP with Nebulizer Kit - Rescuer Emergency CPAP with Large Adult CPAP Mask - B.L.S. Systems Limited

Duns Number:200103823

Device Description: Rescuer Emergency CPAP with Large Adult CPAP Mask and enclosed nebulizer kit (8900)

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More Product Details

Catalog Number

8700-NK

Brand Name

Rescuer Emergency CPAP with Nebulizer Kit

Version/Model Number

8700-NK

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

d84caa9c-6bb0-48be-9fcf-ce8ef281dcdf

Public Version Date

January 14, 2020

Public Version Number

1

DI Record Publish Date

January 06, 2020

Additional Identifiers

Package DI Number

B0028700NK1

Quantity per Package

6

Contains DI Package

B0028700NK0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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