AccessGUDID - DEVICE: Aspiration and Flush Assembly (H862AFALL0)

GUDID

Device Identifier (DI) Information

Brand Name: Aspiration and Flush Assembly
Version or Model: AFA-LL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AFA-LL
Company Name: URESIL, LLC

Primary DI Number: H862AFALL0
Issuing Agency: HIBCC
Commercial Distribution End Date: April 01, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: ASPIRATION FLUSH ADAPTER – LUER LOCK SYSTEM

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?
60538	Luer/Luer linear connector, single-use	A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends 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 nor 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: 4892c196-ec7a-4859-b204-ff7641382b95
Public Version Date: May 20, 2022
Public Version Number: 5
DI Record Publish Date: August 29, 2016