AccessGUDID - DEVICE: CARDINAL HEALTH (20885380106511)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: SA105
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SA105
Company Name: Cardinal Health 200, LLC

Primary DI Number: 20885380106511
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2018
Device Count: 30
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: 0.9% Sodium Chloride Injection, USP Prefilled Syringe, 5ml Fill

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?
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 [?]
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
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: bcd7972e-f549-42dc-9db8-60bd98bc195e
Public Version Date: July 20, 2018
Public Version Number: 4
DI Record Publish Date: August 24, 2016