AccessGUDID - DEVICE: Amxor VacFlush Pre-Filled Normal Saline Flush Syringe (00850049248068)

GUDID

Device Identifier (DI) Information

Brand Name: Amxor VacFlush Pre-Filled Normal Saline Flush Syringe
Version or Model: AVF-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Amxor Healthcare LLC

Primary DI Number: 00850049248068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124112849 *Terms of Use

Device Description: AMXOR VASCFLUSH Pre-Filled Normal Saline Syringe is a pre-filled syringe with saline (0.9% sodium chloride injection, NaCl) and are used to help prevent vascular access systems from becoming blocked and to help remove any medication that may be left at the catheter site.

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?
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NGT	Saline, Vascular Access Flush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220060	000

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
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: a72b1fe8-164e-456b-adb4-d6d5de09bb81
Public Version Date: March 15, 2024
Public Version Number: 1
DI Record Publish Date: March 07, 2024