AccessGUDID - DEVICE: VacuBag (00801741036873)

GUDID

Device Identifier (DI) Information

Brand Name: VacuBag
Version or Model: NDB1000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NDB1000
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741036873
Issuing Agency: GS1
Commercial Distribution End Date: November 14, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: VacuBag

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":	Yes
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?
11301	Closed-wound/centesis drainage receptacle	A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXF	BAG, BILE COLLECTING

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
Total Volume: 1 Liter

Device Record Status

Public Device Record Key: 0d826ebe-3d76-4af8-9e35-37246fcbe139
Public Version Date: April 17, 2024
Public Version Number: 3
DI Record Publish Date: December 04, 2015