AccessGUDID - DEVICE: Spo2 Probe (Older AngioNew® V and VI) (00817980021334)

GUDID

Device Identifier (DI) Information

Brand Name: Spo2 Probe (Older AngioNew® V and VI)
Version or Model: Model AngioNew VI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A12-0035
Company Name: VASOMEDICAL, INC.

Primary DI Number: 00817980021334
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 197210248 *Terms of Use

Device Description: Spo2 Probe (Older AngioNew® V and VI)

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?
17148	Pulse oximeter, line-powered	A mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DRN	Device, counter-pulsating, external

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033617	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: 2f8708fa-a06d-41e5-aeb4-63ae92255800
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 29, 2016