AccessGUDID - DEVICE: Normnal Saline I.V. Flush Syringe (30364253111212)

GUDID

Device Identifier (DI) Information

Brand Name: Normnal Saline I.V. Flush Syringe
Version or Model: 1mL in 6mL Syringe
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MIS-1121
Company Name: MEDEFIL, INC.

Primary DI Number: 30364253111212
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 60
Labeler D-U-N-S® Number*: 016448669 *Terms of Use

Device Description: Medefil Normal Saline IV Flush Syringe, 1mL in 6mL syringe, does not contain natural latex rubber or preservatives, contents and its pathway are sterile. Single Use.

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:	Yes
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?
46309	Vascular catheter flush syringe	A sterile device consisting of a barrel (cylinder) with plunger intended to be used to wash the lumen of a vascular access catheter in situ with a rush of solution to maintain patency. It is prefilled with a saline or low-dose heparin solution, and is typically used when a patient has an intravenous (IV) access device in place. It is not intended for dry product reconstitution, for medication dilution, or where IV therapy with sodium chloride (NaCl) or heparin is indicated. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NGT	Saline, Vascular Access Flush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091583	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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f6484569-805f-41b2-9242-5958bc7d4f00
Public Version Date: November 22, 2018
Public Version Number: 5
DI Record Publish Date: December 09, 2016