AccessGUDID - DEVICE: Vermed (00009336006250)

GUDID

Device Identifier (DI) Information

Brand Name: Vermed
Version or Model: PRG-A520-1043N
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRG-A520-1043N
Company Name: GRAPHIC CONTROLS ACQUISITION CORP

Primary DI Number: 00009336006250
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002111896 *Terms of Use

Device Description: Critikon (J&J)Dinamap and Sensormedics comp.,Adult

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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?
17667	Telemetric pulse oximeter	A portable, photoelectric device intended for the transcutaneous monitoring of haemoglobin oxygen saturation (SpO2) through the radio transmission/reception of SpO2 values. 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) which are radio transmitted to a monitoring site to obviate the need for cabling, promoting the patient's freedom of movement.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter

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: 525e33c3-ebb8-4c9c-b546-02202f927256
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016