Rescuer Emergency CPAP with Medium CPAP Mask 875-NK

GUDID B0028705NK1

Rescuer Emergency CPAP with Medium CPAP Mask and Nebulizer Kit (8900)

B.L.S. Systems Limited

CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use

Primary Device ID	B0028705NK1
NIH Device Record Key	4e5c2e67-7a79-486f-8f6c-3ec824edfb63
Commercial Distribution Status	In Commercial Distribution
Brand Name	Rescuer Emergency CPAP with Medium CPAP Mask
Version Model Number	8705-NK
Catalog Number	875-NK
Company DUNS	200103823
Company Name	B.L.S. Systems Limited
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com
Phone	9053391069
Email	tedreesor@blssystemsltd.com

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0028705NK0 [Primary]
HIBCC	B0028705NK1 [Package] Contains: B0028705NK0 Package: Case [6 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K122610

FDA Product Code

BYE	Attachment, Breathing, Positive End Expiratory Pressure

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-01-14
Device Publish Date	2020-01-06

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