AccessGUDID - DEVICE: ChemoPlus (10884527006212)

GUDID

Device Identifier (DI) Information

Brand Name: ChemoPlus
Version or Model: CP3011G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CP3011G
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527006212
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: Green IVA Seals

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?
16616	Medicine bottle	An empty glass or plastic container, typically with a relatively narrow neck and a lid/cap, intended to be used to store medication so that it retains its viability. This is typically a single-patient device that is reused until the contents are exhausted.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPE	CONTAINER, I.V.

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: ;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7f8c1332-146e-4ac0-ba57-c300f4458478
Public Version Date: May 25, 2023
Public Version Number: 9
DI Record Publish Date: September 24, 2016