Sapphire

Basic Information

• Brand Name: Sapphire
• Primary DI: 10887787007449
• Version / Model: 1638401
• Catalog Number: 1638401
• 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: 2018-06-04
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: cc83cfbb-a68b-4678-98de-27f8a9c3ab61

Device Description

SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 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
MRZ	ACCESSORIES, PUMP, INFUSION	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35833	Electric infusion pump administration set, single-use	A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20887787007446	GS1	Corrugated Box	50	In Commercial Distribution
Primary	10887787007449	GS1
Secondary	M33516384010	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K171346	000

Device Sizes

Type	Value	Unit	Text
Length	123	Inch
Device Size Text, specify			Approximate priming volume : 8.6 Milliliter

Storage Conditions

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