BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

ICU Medical

DI: 00887709030725 · Model: Z3273 · ICU MEDICAL, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

Basic Information

Brand Name: ICU Medical
Primary DI: 00887709030725
Version / Model: Z3273
Company Name: ICU MEDICAL, INC.
Labeler DUNS: 118380146
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2017-11-01
Public Version: 7
Public Version Date: 2021-04-07
Public Version Status: Update
Public Device Record Key: fd455e78-69f9-4daa-9e0f-891e30e6ee7f

Device Description

7" (18 cm) Appx 0.43 ml, Pressure Infusion (400psig) Ext Set w/MicroClave®, Purple Clamp, Rotating Luer

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
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: Yes
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	10887709030722	GS1		50	In Commercial Distribution
Primary	00887709030725	GS1

Premarket Submissions

Submission Number	Supplement Number
K100576	000