AccessGUDID - DEVICE: Flexicare (05055931103868)

GUDID

Device Identifier (DI) Information

Brand Name: Flexicare
Version or Model: 010-708U
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FLEXICARE MEDICAL LIMITED

Primary DI Number: 05055931103868
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 504406273 *Terms of Use

Device Description: Bi-PAP Connector 22m-15F/22m with Exhaust Valve & Bacterial / Viral Filters (Patient & Machine End)

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:	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?
60657	Non-rebreathing valve, single-use	A non-sterile device containing a one-way valve intended to be used to direct the flow of breathing gases, typically in a breathing circuit or between an oxygen mask and its reservoir bag, to prevent patient rebreathing of exhaled gases. The device is available in various designs and includes unidirectional valves made of various materials (e.g., silicone, rubber, metal, or mica sheets/discs) that typically open and close with each inspiration/expiration. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAH	Filter, Bacterial, Breathing-Circuit

FDA Premarket Submission

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

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: e7ab8d48-f95a-4bc2-a64f-d8bfb06329c3
Public Version Date: December 30, 2024
Public Version Number: 2
DI Record Publish Date: March 13, 2024