Angio-Seal™

Basic Information

• Brand Name: Angio-Seal™
• Primary DI: 05415067002846
• Version / Model: Evolution™
• Catalog Number: C610135
• Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
• Labeler DUNS: 040960379
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-10-24
• Public Version: 5
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: d67f054a-14cd-4ce5-a7b6-cf590bf6f595
• Distribution End Date: 2017-04-20

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: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MGB	DEVICE, HEMOSTASIS, VASCULAR	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60710	Femoral artery closure plug/patch, collagen	An implantable, bioabsorbable device designed for haemostasis/closure of a puncture site, through pressure/compression, on a patient having undergone femoral artery catheterization; it is intended as an alternative to manual compression or surgical techniques to reduce the time to haemostasis. It consists of an animal-derived collagen plug that is implanted using an included delivery device (e.g., guidewire, hand-held delivery unit) onto the extravascular surface of the femoral artery access site (top of arteriotomy site), and may be held in place with an included synthetic, bioabsorbable patch/anchor/suture to achieve haemostasis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067002846	GS1
Package	25415067002840	GS1		5	Not in Commercial Distribution	2017-04-20
Package	15415067002843	GS1		2	Not in Commercial Distribution	2017-04-20

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	8	French

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.