AccessGUDID - DEVICE: EDOCS (00860007698200)

GUDID

Device Identifier (DI) Information

Brand Name: EDOCS
Version or Model: EDOCS 120B-21
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 793720-001
Company Name: Pacific Consolidated Industries LLC

Primary DI Number: 00860007698200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 120848411 *Terms of Use

Device Description: EDOCS 120B-21 FINAL ASSEMBLY - 120 LPM AT 85 PSI, 60 LPM AT 2250 PSI, 208-240V/50-60 HZ

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?
57850	Bulk oxygen concentration system	A stationary assembly of mains electricity (AC-powered) devices designed to concentrate oxygen (O2) from ambient air and then deliver the concentrated O2, with purity of up to 99.5%, to the hospital medical gas supply system. It may produce high-purity O2 using pressure swinging adsorption (PSA) technology which processes air through internal molecular sieves having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, refrigeration dryer, water and oil separators, high pressure O2 pump and various storage tanks. The concentrated O2 is delivered via the medical gas supply system to the user and/or a gas cylinder filling station.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAW	Generator, Oxygen, Portable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061414	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: 467a4fdc-339c-41c0-b1a1-adcf844cb115
Public Version Date: May 16, 2023
Public Version Number: 1
DI Record Publish Date: May 08, 2023