AccessGUDID - DEVICE: Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit™ (00801741113222)

GUDID

Device Identifier (DI) Information

Brand Name: Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit™
Version or Model: EN0046100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EN0046100
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741113222
Issuing Agency: GS1
Commercial Distribution End Date: February 29, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit™

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?
14221	Nasogastric feeding tube	A sterile, thin, flexible, hollow cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily for enteral feeding and the administration of medications, either by gravity or with a pump; it may also be used for aspiration of gastric contents (e.g., gastric secretions). It is typically a single lumen, rubber or plastic tube of various diameters (typically smaller than those of nasogastric tubes intended primarily for decompression) with circular markings that serve as insertion guides. It is frequently used for very ill or comatose patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEG	TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

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: 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
Catheter Gauge: 10 French
Length: 36 Inch

Device Record Status

Public Device Record Key: b9794aba-9079-44ae-9682-3fa6bc07e390
Public Version Date: November 06, 2024
Public Version Number: 3
DI Record Publish Date: September 19, 2016