AccessGUDID - DEVICE: Rescuer II Compact CPAP System with Medium Deluxe CPAP Mask and Nebulizer Kit (B0028805NK0)

GUDID

Device Identifier (DI) Information

Brand Name: Rescuer II Compact CPAP System with Medium Deluxe CPAP Mask and Nebulizer Kit
Version or Model: 8805-NK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8805-NK
Company Name: B.L.S. Systems Limited

Primary DI Number: B0028805NK0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 200103823 *Terms of Use

Device Description: Rescuer II Compact CPAP with Medium Deluxe CPAP Mask and Nebulizer Kit

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?
61656	In-line CPAP set, nebulizing	A portable collection of devices intended to be connected to a medical gas supply to assist noninvasive ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It includes an in-line/gas-line CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a face mask, a nebulizer, and may include additional components (e.g., manometer, flowmeter, tubing, mask strap). This is a reusable device once the consumable products have been replenished.	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: Medium

Device Record Status

Public Device Record Key: e15511e8-0ac9-4518-a2f3-05e2c98ff754
Public Version Date: November 02, 2018
Public Version Number: 1
DI Record Publish Date: October 02, 2018