AccessGUDID - DEVICE: Monoject (10884521014855)

GUDID

Device Identifier (DI) Information

Brand Name: Monoject
Version or Model: 8881204005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8881204005
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521014855
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 500
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Medication Transfer 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):	No
Over the Counter (OTC):	Yes
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?
16266	Medication transfer needle, filtering	A slender, rigid, sharp or blunt tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication; it does not include a back-pressure venting feature. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAA	NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

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
Device Size Text, specify: Needle Gauge,20,Gauge;
Length: 1 Inch

Device Record Status

Public Device Record Key: 4facf85a-f002-4ca3-bbb0-316edde76e7a
Public Version Date: January 08, 2025
Public Version Number: 4
DI Record Publish Date: June 29, 2018