AccessGUDID - DEVICE: Interactive Breath Hold Monitor (00851607003082)

GUDID

Device Identifier (DI) Information

Brand Name: Interactive Breath Hold Monitor
Version or Model: IBC01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 43T0970
Company Name: MEDSPIRA, LLC

Primary DI Number: 00851607003082
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

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):	Yes
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
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Special Storage Condition, Specify: Product should be kept dry
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 41b65461-3234-49f6-a2aa-d6e44a960713
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
10851607003089	1	00851607003082		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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