AccessGUDID - DEVICE: Venting Needle (B21231201)

GUDID

Device Identifier (DI) Information

Brand Name: Venting Needle
Version or Model: 31-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31-20
Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.

Primary DI Number: B21231201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053469565 *Terms of Use

Device Description: Venting Needle Filtered with 0.2 Micron Hydrophobic filter, white filter housing, 20 gauge x 1.5" stainless steel non-coring needle, sterile, individual blister pack, box of 100

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?
63459	Hydrophobic Luer filter	A device intended to be attached to equipment during a medical/surgical procedure and/or to a needle during drug preparation (i.e., vial venting) to prevent the transfer of microbes, particulates and aerosols while allowing passage of air/gas; its use is not dedicated to a specific type of medical equipment. It is a small plastic housing containing a hydrophobic filter with male and female Luer connections (Luer-lock or Luer-slip). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHI	Set, I.V. Fluid Transfer

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
No Device Sizes

Device Record Status

Public Device Record Key: b028d26e-482b-4447-b36f-0a5393225dcc
Public Version Date: April 26, 2024
Public Version Number: 4
DI Record Publish Date: August 22, 2016