AccessGUDID - DEVICE: ExpanSure Transseptal Dilation System (00685447003021)

GUDID

Device Identifier (DI) Information

Brand Name: ExpanSure Transseptal Dilation System
Version or Model: ESD125-35-67-70-N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Baylis Médicale Cie Inc

Primary DI Number: 00685447003021
Issuing Agency: GS1
Commercial Distribution End Date: October 23, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 249225954 *Terms of Use

Device Description: One transseptal dilator; one J-tip guidewire.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRE	Dilator, Vessel, For Percutaneous Catheterization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182064	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Device Size Text, specify: 12.5F 67cm Transseptal Dilator with Max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.81mm and tip shape = 3mm J; Max Guidewire OD = 0.89mm.

Device Record Status

Public Device Record Key: db4219b4-d4b4-4b9c-b9de-bd9b0303b7a5
Public Version Date: December 08, 2023
Public Version Number: 6
DI Record Publish Date: April 10, 2019