AccessGUDID - DEVICE: Monoject (20884521128917)

GUDID

Device Identifier (DI) Information

Brand Name: Monoject
Version or Model: 8881114063
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8881114063
Company Name: Cardinal Health, Inc.

Primary DI Number: 20884521128917
Issuing Agency: GS1
Commercial Distribution End Date: February 22, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: 140 mL Piston Syringe,Luer-Lock Tip

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
FMF	Syringe, piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: Keep Dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 140 Milliliter
Total Volume: 12 Milliliter
Total Volume: 20 Milliliter
Total Volume: 60 Milliliter
Total Volume: 6 Milliliter
Total Volume: 35 Milliliter
Total Volume: 3 Milliliter
Total Volume: 18 Gallon

Device Record Status

Public Device Record Key: 27ab097f-a9c0-4d8f-99dc-78a3d8f33dce
Public Version Date: February 23, 2021
Public Version Number: 7
DI Record Publish Date: September 24, 2016