AccessGUDID - DEVICE: Buffalo Filter (00851136002631)

GUDID

Device Identifier (DI) Information

Brand Name: Buffalo Filter
Version or Model: Armstand
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Buffalo Filter

Primary DI Number: 00851136002631
Issuing Agency: GS1
Commercial Distribution End Date: April 21, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 787855907 *Terms of Use

Device Description: Tubing stand/holder

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:	No
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Intravenous pole	A metal rod with two or more hooked bars extending horizontally from its top from which various fluid delivery devices (bags or bottles) can be suspended for the administration of intravenous (IV) fluids/medication to the patient. It is used during infusion therapy for intravenous administration of fluids/solutions or blood transfusions. Infusion pumps and/or syringe pumps can also be attached to it. Commonly known as an IV pole or drip pole, it can be a fixed or side-swinging, adjustable, vertical pole attached to a bed or operating table, or more commonly, an independent floor-standing IV pole for bedside use; some have wheels to allow patient mobility.

GMDN Preferred Term Name

GMDN Definition

Intravenous pole

A metal rod with two or more hooked bars extending horizontally from its top from which various fluid delivery devices (bags or bottles) can be suspended for the administration of intravenous (IV) fluids/medication to the patient. It is used during infusion therapy for intravenous administration of fluids/solutions or blood transfusions. Infusion pumps and/or syringe pumps can also be attached to it. Commonly known as an IV pole or drip pole, it can be a fixed or side-swinging, adjustable, vertical pole attached to a bed or operating table, or more commonly, an independent floor-standing IV pole for bedside use; some have wheels to allow patient mobility.

FDA Product Code

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Product Code	Product Code Name
FOX	Stand, Infusion

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: caa26a72-5316-4701-aea2-d5aae062cdf9
Public Version Date: April 22, 2022
Public Version Number: 3
DI Record Publish Date: January 13, 2017