AccessGUDID - DEVICE: Vermed (00009336006236)

GUDID

Device Identifier (DI) Information

Brand Name: Vermed
Version or Model: CB-A400-1027A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CB-A400-1027A
Company Name: GRAPHIC CONTROLS ACQUISITION CORP

Primary DI Number: 00009336006236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002111896 *Terms of Use

Device Description: SensorMedics Spo2 Adapter Cable

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?
36118	Pulse oximetry telemetric monitoring system	An assembly of devices designed to continuously measure and wirelessly transmit haemoglobin oxygen saturation (SpO2) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).	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: d82a8a7b-8379-4fff-a5f8-84cd47849611
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016