AccessGUDID - DEVICE: EndoVive™ One Step Button™ (08714729150084)

GUDID

Device Identifier (DI) Information

Brand Name: EndoVive™ One Step Button™
Version or Model: M00568460
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M00568460
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729150084
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Low Profile Percutaneous Endoscopic Gastrostomy Kit

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?
11677	Enteral feeding kit, adult/paediatric, sterile	A collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KGC	TUBE, GASTRO-ENTEROSTOMY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: 18 F Diameter
Device Size Text, specify: 6.0 mm Diameter
Device Size Text, specify: 2.4 cm Length

Device Record Status

Public Device Record Key: 5e8f70be-df86-4cbf-b04d-702b06d3f5e5
Public Version Date: October 08, 2018
Public Version Number: 1
DI Record Publish Date: September 07, 2018