AccessGUDID - DEVICE: DRIVE (00822383584317)

GUDID

Device Identifier (DI) Information

Brand Name: DRIVE
Version or Model: KI-18302GDEL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383584317
Issuing Agency: GS1
Commercial Distribution End Date: February 29, 2024
Device Count: 20
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Respiratory Regulators Product Description K&I,Reg CGA870, 0-15L w/Diss, 20/cv

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
31760	Fixed-regulator oxygen refillable cylinder	A container designed as a refillable cylinder with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAN	REGULATOR, PRESSURE, GAS CYLINDER

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: 12555d49-d420-49ef-91f8-47679973ae3b
Public Version Date: March 01, 2024
Public Version Number: 3
DI Record Publish Date: February 01, 2020