AccessGUDID - DEVICE: VTI Oxygen Analyzer (00817122020010)

GUDID

Device Identifier (DI) Information

Brand Name: VTI Oxygen Analyzer
Version or Model: 102200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 102200
Company Name: VASCULAR TECHNOLOGY, INCORPORATED

Primary DI Number: 00817122020010
Issuing Agency: GS1
Commercial Distribution End Date: May 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 161989343 *Terms of Use

Device Description: Part Number 102200 VTI Oxygen Analyzer

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:	No
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?
46049	Respiratory oxygen monitor, battery-powered	A battery-powered instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting (e.g., O2 in an anaesthesia or ventilator breathing circuit, oxygen tent, oxygen therapy device/system tubing). It typically consists of an electronic unit with a display to show actual values of percentage of O2 concentration, a sensor to detect the O2 values, control knobs or buttons, and an alarm to alert when O2 values are beyond a predetermined range.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCL	ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K922738	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: b3480cd9-516f-4aac-80eb-3060b9a7e296
Public Version Date: June 02, 2025
Public Version Number: 4
DI Record Publish Date: September 20, 2016