AccessGUDID - DEVICE: Monoject (20884527002839)

GUDID

Device Identifier (DI) Information

Brand Name: Monoject
Version or Model: 1270013000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1270013000
Company Name: Cardinal Health, Inc.

Primary DI Number: 20884527002839
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 1000
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Sample Cup for 13 mm Tubes

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?
66068	Test tube/reservoir cap IVD	A covering intended to be used to seal the top of an in vitro diagnostic test tube or reagent reservoir to protect the contents against contamination from the external environment, and to prevent spillage and/or evaporation of contents during transportation or processing. The top of the cap may be penetrable to enable injection or aspiration of contents. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection

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: No
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
Outer Diameter: 13 Millimeter
Total Volume: 1.0 Milliliter

Device Record Status

Public Device Record Key: fc432523-eacd-42b9-ac77-d2cd1dbd75ce
Public Version Date: January 10, 2025
Public Version Number: 4
DI Record Publish Date: June 29, 2018