AccessGUDID - DEVICE: 3100 HFOV (10190752155381)

GUDID

Device Identifier (DI) Information

Brand Name: 3100 HFOV
Version or Model: 770150
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 770150
Company Name: VYAIRE MEDICAL, INC.

Primary DI Number: 10190752155381
Issuing Agency: GS1
Commercial Distribution End Date: November 05, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080456871 *Terms of Use

Device Description: Scavenger for 3100A / 3100B High Frequency Oscillatory Ventilators

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):	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?
61346	Straight/elbow breathing circuit connector, single-use	A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSZ	VENTILATOR, HIGH FREQUENCY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P890057	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: f411fb38-44ca-4214-8d76-a6ce849ce661
Public Version Date: November 06, 2024
Public Version Number: 3
DI Record Publish Date: February 08, 2021