AccessGUDID - DEVICE: Rugged Oxygen Generator (ROG) (05060031380002)

GUDID

Device Identifier (DI) Information

Brand Name: Rugged Oxygen Generator (ROG)
Version or Model: EO209P63N29
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MOLECULAR PRODUCTS LIMITED

Primary DI Number: 05060031380002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 345709885 *Terms of Use

Device Description: The ROG is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 Lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.

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:	Yes
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?
61062	Emergency oxygen production unit, reusable	A portable, non-electric device designed to produce medical grade oxygen, from activated chemicals, to administer to patients in first aid or emergency situations (e.g., cardiac emergencies, asthma/COPD exacerbations, shock/ trauma in the field). It consists of a reusable housing with an activation button, a single-use breathing apparatus (e.g., mask/tubing), and a replaceable single-use oxygen-generating chemical cartridge. The device is intended to be used by healthcare professionals and laypersons. This is a reusable device upon replacement of single-use components.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAW	Generator, Oxygen, Portable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131016	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
Storage Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf33c996-f360-46f8-a3f6-51b740ea834b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 26, 2016