AccessGUDID - DEVICE: Roscoe Medical (00815067013371)

GUDID

Device Identifier (DI) Information

Brand Name: Roscoe Medical
Version or Model: 50052
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: COMPASS HEALTH BRANDS CORP.

Primary DI Number: 00815067013371
Issuing Agency: GS1
Commercial Distribution End Date: May 07, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 827221698 *Terms of Use
Previous DI: 00092237604595

Device Description: Finger Pulse Oximeter, OTC

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):	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?
37808	Pulse oximeter probe, reusable	A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCH	Oximeter, Infrared, Sporting, Aviation

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: 51e436ad-98c7-4553-a4fb-3802ce3e440a
Public Version Date: September 01, 2023
Public Version Number: 5
DI Record Publish Date: November 30, 2016