AccessGUDID - DEVICE: Aspiration and Flush Assembly (H862AFA20P0)

GUDID

Device Identifier (DI) Information

Brand Name: Aspiration and Flush Assembly
Version or Model: AFA-20P
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AFA-20P
Company Name: URESIL, LLC

Primary DI Number: H862AFA20P0
Issuing Agency: HIBCC
Commercial Distribution End Date: January 21, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM WITH FUNNEL

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:	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?
64467	Luer/non-ISO80369-standardized linear connector, single-use	A small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, bayonet, collet, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing or an external puncturing component. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBO	Catheter, Nephrostomy, General & Plastic Surgery

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: 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: 095ab376-34a9-4b5d-a5c8-d0f8bf5c4d92
Public Version Date: November 19, 2020
Public Version Number: 6
DI Record Publish Date: August 24, 2016