AccessGUDID - DEVICE: Resp-O2 Venturi Select A Vent Elongated Pediatric Masks (00840117310810)

GUDID

Device Identifier (DI) Information

Brand Name: Resp-O2 Venturi Select A Vent Elongated Pediatric Masks
Version or Model: 33071
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00840117310810
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: 7' (2.1m) Crush Resistant Tubing, Standard Connector. Components: 1- Pediatric Mask, 1- 6" Flex Tube, 1- Humidity Connector, 1- 7' Oxygen Tubing, 6- Diluters (Blue 24%, Yellow 28%, White 31%, Green 35%, Pink 40%, Orange 50%)

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?
35175	Venturi oxygen face mask	A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. The device typically includes a variety of exchangeable inserts (the venturi) that allow air entrainment in controlled amounts to provide the desired O2 concentration. It is connected to an O2 source with tubing and includes headstraps for stabilization. Adaptors are typically included for connection to a humidification source. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYF	Mask, Oxygen, Low Concentration, Venturi

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: 35abe774-cba1-4735-b27f-a951e4d02c8d
Public Version Date: October 09, 2024
Public Version Number: 3
DI Record Publish Date: April 22, 2021