AccessGUDID - DEVICE: Monoject (20884521014135)

GUDID

Device Identifier (DI) Information

Brand Name: Monoject
Version or Model: 8881516051
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8881516051
Company Name: Cardinal Health, Inc.

Primary DI Number: 20884521014135
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2023
Device Count: 50
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: 6 mL Syringe with Standard Hypodermic Needle

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?
35904	Metered-delivery hypodermic syringe	A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. 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: 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: Keep dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e01f135d-6af0-48b4-b22c-ad6d2d5cf464
Public Version Date: January 02, 2023
Public Version Number: 7
DI Record Publish Date: February 16, 2017