AccessGUDID - DEVICE: Model 2104 Tubing Kit (08714729454533)

GUDID

Device Identifier (DI) Information

Brand Name: Model 2104 Tubing Kit
Version or Model: M0043521040
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M0043521040
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729454533
Issuing Agency: GS1
Commercial Distribution End Date: December 16, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Peristaltic Pump Delivery Extension Tube Set

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:	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?
44772	Cardiac ablation system irrigation tubing set	A collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPB	Cardiac ablation percutaneous catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P980003	000
P980003	001
P980003	002
P980003	004
P980003	005
P980003	007
P980003	008
P980003	009
P980003	010
P980003	013
P980003	015
P980003	016
P980003	018
P980003	019
P980003	020
P980003	021
P980003	025
P980003	027
P980003	030
P980003	031
P980003	034
P980003	038
P980003	041
P980003	045

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
No Device Sizes

Device Record Status

Public Device Record Key: 86e9db02-2988-41cb-9f99-3428074ec0cb
Public Version Date: July 11, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2014