AccessGUDID - DEVICE: Auto-Fill® syringe kit (M20676000)

GUDID

Device Identifier (DI) Information

Brand Name: Auto-Fill® syringe kit
Version or Model: 7600
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20676000
Issuing Agency: HIBCC
Commercial Distribution End Date: November 04, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *Terms of Use

Device Description: The AUTO-FILL Syringe Kit is indicated for introduction of dilute lidocaine solutions into the subcutaneous tissue for the purposes of local anesthesia.

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:	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?
37589	Syringe autofill kit	A collection of sterile devices designed to deliver (autofill) fluids (e.g., a dilute lidocaine solution for local anaesthesia) from an intravenous (IV) bag to a syringe so that the syringe is conveniently refilled, thus eliminating the need for multiple reconnections to the solution container. It is typically made of plastic materials and consists of a 12 cc control syringe, IV tubing with a spike, check valve and tubing clamp, and an extension line. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, Administration, Intravascular
FMF	Syringe, Piston

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: 1fceda93-0259-45f4-af00-0c5e5859f1fd
Public Version Date: June 09, 2023
Public Version Number: 5
DI Record Publish Date: September 06, 2016