AccessGUDID - DEVICE: Monoject (10192253063271)

GUDID

Device Identifier (DI) Information

Brand Name: Monoject
Version or Model: 8881511201
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8881511201
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10192253063271
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Tuberculin Safety Syringe with 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?
34973	Insulin syringe/needle, safety	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, hypodermic, single lumen
FMF	Syringe, piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192551	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 28 Gauge
Length: 0.5 Inch

Device Record Status

Public Device Record Key: 2b4953a7-12c4-4858-91fc-2519434ba823
Public Version Date: June 30, 2025
Public Version Number: 6
DI Record Publish Date: July 14, 2023