AccessGUDID - DEVICE: SMARTFREEZE™ (08714729992783)

GUDID

Device Identifier (DI) Information

Brand Name: SMARTFREEZE™
Version or Model: M004CRBS6110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M004CRBS6110
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729992783
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Diaphragm Movement Sensor

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):	Yes
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?
64689	Cardiac ablation thoracic motion sensor	A small electronic device intended to be placed on a patient’s chest during a cardiac ablation procedure to sense diaphragmatic movement as a means to assess potential phrenic nerve damage. It is intended to be used in conjunction with a separate monitor and senses motion based on accelerometery; it does not include any patient electrodes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220032	000

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: 5194390b-6205-441e-a6c8-8f63e1fe4b15
Public Version Date: August 29, 2023
Public Version Number: 1
DI Record Publish Date: August 21, 2023