LifeStream

Basic Information

• Brand Name: LifeStream
• Primary DI: 05391522080966
• Version / Model: LSMU0800537
• Catalog Number: LSMU0800537
• Company Name: CLEARSTREAM TECHNOLOGIES LIMITED
• Labeler DUNS: 989214291
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-26
• Public Version: 6
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 46220bab-dfbf-494b-84e4-77dbab965e1c

Device Description

LifeStream™ Balloon Expandable Vascular Covered Stent, 5 mm x 37 mm, 80 cm catheter length

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: MR Conditional
• 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
PRL	Iliac covered stent, arterial	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
43526	Peripheral artery endovascular stent-graft, non-medicated	A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes coronary and intracranial arteries) to maintain patency and improve luminal diameter, typically in patients with symptomatic peripheral vascular disease or following the recanalization of a total occlusion; it may in addition be intended for optional venous implantation. It does not include anticoagulant or antiproliferative pharmaceuticals. It is a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft) available in various sizes. It is percutaneously inserted with a disposable delivery device which may be included with the stent-graft.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391522080966	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Implant Length, 37 Millimeter
Device Size Text, specify			Balloon Diameter, 5 Millimeter
Device Size Text, specify			Catheter Length, 80 Centimeter