AccessGUDID - DEVICE: SILENTE, INTERSURGICAL ECOLITE™, ADULT, ADJUSTABLE VENTURI MASK KIT AND TUBE (05030267157877)

GUDID

Device Identifier (DI) Information

Brand Name: SILENTE, INTERSURGICAL ECOLITE™, ADULT, ADJUSTABLE VENTURI MASK KIT AND TUBE
Version or Model: 1137016
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Intersurgical Incorporated

Primary DI Number: 05030267157877
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785952607 *Terms of Use

Device Description: SILENTE, INTERSURGICAL ECOLITE™, ADULT, ADJUSTABLE VENTURI MASK KIT AND TUBE WITH UNIVERSAL CONNECTOR, 1.8M

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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
BYG	Mask, Oxygen

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: e826925f-fdec-4672-8508-6b1fa8843d92
Public Version Date: February 11, 2025
Public Version Number: 2
DI Record Publish Date: November 09, 2023