AccessGUDID - DEVICE: Monitor System, IBC Base Unit (00851607003136)

GUDID

Device Identifier (DI) Information

Brand Name: Monitor System, IBC Base Unit
Version or Model: 43T2631
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDSPIRA, LLC

Primary DI Number: 00851607003136
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, IBC Base Unit

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?
56622	Breath-hold system base station	A battery-powered component of a breath-hold system designed to electronically receive a patient's mechanical respiratory movements, detected by a patient belt, convert these to electronic values and wirelessly transmit signals to a remote display that is viewed by the patient for instruction on when and how long to hold their breath. This device may also function as a holder and a charger for multiple remote displays when connected to the main electrical supply.	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: d1d3406f-0188-4c6e-91b1-1c01ac8f8be8
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 09, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10851607003133	5	00851607003136		In Commercial Distribution	Shipper

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 612-789-0013
Email: info@medspira.com

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