AccessGUDID - DEVICE: Roscoe Medical (00092237615751)

GUDID

Device Identifier (DI) Information

Brand Name: Roscoe Medical
Version or Model: ROS-50044
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: COMPASS HEALTH BRANDS CORP.

Primary DI Number: 00092237615751
Issuing Agency: GS1
Commercial Distribution End Date: May 07, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 827221698 *Terms of Use

Device Description: Roscoe Single Lumen Conserver,

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?
13538	Respiratory oxygen sensor	A device designed to detect the presence and determine the concentration of oxygen (O2) by paramagnetic, electrochemical, or other technique. The device is typically used as a component of an oxygen monitor or a patient monitoring device/system that determines the percentage of O2 in medical gases used in an enclosed atmosphere (e.g., an anaesthesia or ventilator circuit, oxygen tent, oxygen therapy device/system tubing) inspired by a patient. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFB	Conserver, Oxygen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 6650ae1f-620e-4f14-8dcc-30dce8e3ab24
Public Version Date: August 23, 2023
Public Version Number: 4
DI Record Publish Date: October 07, 2016