AccessGUDID - DEVICE: DRIVEMEDICAL (00822383126548)

GUDID

Device Identifier (DI) Information

Brand Name: DRIVEMEDICAL
Version or Model: 18140
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383126548
Issuing Agency: GS1
Commercial Distribution End Date: August 06, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: RespiratoryCarts/racks/cases/stands Product Description: OxyCylRack E,D,C,M9 fits20 1ea

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):	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?
47225	Oxygen refillable cylinder	A container designed as a refillable cylinder 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 valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials and must be used together with a pressure regulator in order to release the O2 at the correct working pressure. 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
PCM	Portable liquid oxygen unit stand

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: 9108de50-b35c-40d2-a04e-afc070b75187
Public Version Date: August 15, 2024
Public Version Number: 3
DI Record Publish Date: June 21, 2019