Plum

Basic Information

• Brand Name: Plum
• Primary DI: 00887709102033
• Version / Model: 24002
• Catalog Number: 240020401
• Company Name: ICU MEDICAL, INC.
• Labeler DUNS: 118380146
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-25
• Public Version: 1
• Public Version Date: 2022-09-02
• Public Version Status: New
• Public Device Record Key: 5a585983-34e6-4fd8-ad7a-63ccdb17ea3b

Device Description

PLUM Enteral Set with ENFit Connector, ENPlus Piercing Pin, 96 Inch

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64461	Enteral feeding noninvasive-component set	A collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10887709102030	GS1	Corrugated Box	50	In Commercial Distribution
Primary	00887709102033	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K141789	000

Device Sizes

Type	Value	Unit	Text
Length	96	Inch
Device Size Text, specify			Approximate Priming Volume: 17 mL; Drop Size: 20 Drops/mL