AccessGUDID - DEVICE: Bard® Blakemore Esophageal-Nasogastric Tube (00801741076831)

GUDID

Device Identifier (DI) Information

Brand Name: Bard® Blakemore Esophageal-Nasogastric Tube
Version or Model: 0092300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0092300
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741076831
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bard® Blakemore Esophageal-Nasogastric Tube

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):	Yes
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?
35416	Oesophageal varices haemostatic tube	A flexible, hollow cylinder with an inflatable balloon(s) and aspiration port(s) intended to be non-surgically inserted into the oesophagus and stomach, through the nose or mouth, to tampon bleeding oesophageal varices. The device is also known as a Sengstaken, Blakemore, Linton or Minnesota tube. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 39 Inch
Catheter Gauge: 16 French

Device Record Status

Public Device Record Key: 6f06f09f-53cd-4d14-a893-a01212b93456
Public Version Date: December 23, 2019
Public Version Number: 3
DI Record Publish Date: July 28, 2016