AccessGUDID - DEVICE: Monitor System, US Power Cord & Convertor (00851607003150)

GUDID

Device Identifier (DI) Information

Brand Name: Monitor System, US Power Cord & Convertor
Version or Model: M43T1071
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDSPIRA, LLC

Primary DI Number: 00851607003150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962187964 *Terms of Use

Device Description: Interactive Breath Hold - Monitor System, US Power Cord & Convertor

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):	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?
56621	Breath-hold system	An assembly of portable electronic devices designed to provide bio-feedback to a patient to indicate when they should hold their breath during a procedure requiring precise location of target tissues potentially compromised by respiratory motion. It typically consists of a base station, multiple remote (wireless) displays that provide feedback to the patient and healthcare staff, patient respiration belts, and software. It is used for image-guided biopsy procedures, radio-frequency (RF) ablation, cryoablation, marker introduction, and often in conjunction with radiological systems, e.g., computed tomography (CT) and/or imaging ultrasound (US).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCC	Device, Biofeedback

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: ddd56a9d-2326-4aae-a9ac-cb2424ab1ee5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 09, 2017