AccessGUDID - DEVICE: Monoject (30884521163670)

GUDID

Device Identifier (DI) Information

Brand Name: Monoject
Version or Model: 8881579121
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8881579121
Company Name: Cardinal Health, Inc.

Primary DI Number: 30884521163670
Issuing Agency: GS1
Commercial Distribution End Date: February 18, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: 0.9% Sodium Chloride,Flush Syringe, 10 mL 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":	No
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 [?]
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
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: adb679ec-993d-43fa-b02a-c12c1f0c448c
Public Version Date: January 06, 2025
Public Version Number: 7
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10884521163676	100	30884521163670	2021-02-18	Not in Commercial Distribution	PACK_OR_INNER_PACK
20884521163673	800	30884521163670	2021-02-18	Not in Commercial Distribution	CASE