AccessGUDID - DEVICE: Expel™ Large Capacity Drainage Catheter Connecting Tube (08714729862949)

GUDID

Device Identifier (DI) Information

Brand Name: Expel™ Large Capacity Drainage Catheter Connecting Tube
Version or Model: H7493938000150
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729862949
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Connecting Tube

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
46115	General-purpose catheter connector, sterile	A small sterile device intended to create a mechanical union between a catheter and an external device (non-dedicated) typically via a Luer connection; it has an intended use profile that is not dedicated to a specific type of catheter (i.e., can be applied to catheters specific to different anatomical sites and body fluids). It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KGZ	ACCESSORIES, CATHETER

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: 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: 15 cm Length

Device Record Status

Public Device Record Key: 0ea5e94c-5f53-4119-b498-b23dbeaacef6
Public Version Date: August 09, 2018
Public Version Number: 3
DI Record Publish Date: August 25, 2016