Plum

Basic Information

• Brand Name: Plum
• Primary DI: 10887787003236
• Version / Model: 1495488
• Catalog Number: 1495488
• Company Name: ICU MEDICAL FLEET SERVICES, LLC
• Labeler DUNS: 830767898
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-31
• Public Version: 4
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: db3d9d67-2350-4d84-88ae-f058d1c15260

Device Description

Primary PLUM Set 0.2 Micron Filter, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 112 Inch (previously Hospira product)

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: Yes
• 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
58977	Basic intravenous administration set, noninvasive	A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20887787003233	GS1	case	24	In Commercial Distribution
Primary	10887787003236	GS1
Secondary	M33514954880	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141789	000

Device Sizes

Type	Value	Unit	Text
Length	112	Inch
Device Size Text, specify			Approximate priming volume : 24 Milliliter
Device Size Text, specify			Drop Size : 15 Drops / Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature. Avoid Excessive Heat. Protect from Freezing