AccessGUDID - DEVICE: Respironics BiPAP Pro, Plus, Duet LX, Synchrony Style Ultrafine Filters (00848530030483)

GUDID

Device Identifier (DI) Information

Brand Name: Respironics BiPAP Pro, Plus, Duet LX, Synchrony Style Ultrafine Filters
Version or Model: CF1005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CF1005
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530030483
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Respironics BiPAP Pro, Plus, Duet LX, Synchrony Style Ultrafine Filters (6/pack)

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:	No
Prescription Use (Rx):	No
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?
63172	CPAP/BPAP unit ambient air filter, reusable	A non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It is typically a flat sheet or pad composed of tightly woven materials or foam intended to be installed over the air inlet of the CPAP/BPAP device to remove particulates/impurities; it is not intended to filter microbes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JRL	Unit, Filter, Membrane

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 3ecd05ce-8681-410f-8e55-7ee301aa4630
Public Version Date: June 29, 2018
Public Version Number: 1
DI Record Publish Date: May 29, 2018