AccessGUDID - DEVICE: Breas iSleep 20i system (07321822070006)

GUDID

Device Identifier (DI) Information

Brand Name: Breas iSleep 20i system
Version or Model: US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 207000
Company Name: Breas Medical AB

Primary DI Number: 07321822070006
Issuing Agency: GS1
Commercial Distribution End Date: January 15, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 357007657 *Terms of Use

Device Description: Ventilator Non-continuous (Respirator)

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":	No
For Single-Use:	No
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?
60711	Home CPAP unit	A portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZD	Ventilator, Non-Continuous (Respirator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063476	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6adde063-2d34-4293-a816-f5259869e7d8
Public Version Date: February 11, 2021
Public Version Number: 4
DI Record Publish Date: September 20, 2016