AccessGUDID - DEVICE: Rescuer II Compact CPAP System (B00288000)

GUDID

Device Identifier (DI) Information

Brand Name: Rescuer II Compact CPAP System
Version or Model: 8800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8800
Company Name: B.L.S. Systems Limited

Primary DI Number: B00288000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 200103823 *Terms of Use

Device Description: The Rescuer II Compact CPAP System is a more compact version of the Rescuer Emergency CPAP System, intended to be used on patients exhibiting acute respiratory distress. The 8800 model is packaged with a Large Adult CPAP mask and pre-attached bonnet.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57813	CPAP/BPAP face mask, single-use	A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYE	Attachment, Breathing, Positive End Expiratory Pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122610	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Large CPAP Mask

Device Record Status

Public Device Record Key: f529912c-6ccc-4fcc-a419-7192d72e4986
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: July 20, 2015