Closer Vascular Sealing System

Basic Information

• Brand Name: Closer Vascular Sealing System
• Primary DI: 10857141005251
• Version / Model: 202704
• Catalog Number: 202704
• Company Name: Rex Medical LLP
• Labeler DUNS: 079535216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-03-28
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ed28e3a1-9697-4671-953c-0877a9564f26

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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
MGB	Device, Hemostasis, Vascular	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46370	Femoral artery compression system, single-use	An assembly of sterile devices intended to be used in conjunction with manual compression to facilitate haemostasis to the puncture site on a patient having undergone femoral artery catheterization. It typically consists of a dedicated catheter with an elastomeric membrane at the distal tip and a tensioner. The catheter is inserted through the previously placed catheter introducer sheath and, once positioned, the membrane is deployed in the inner lumen of the femoral artery. Tension is applied to keep the membrane against the arteriotomy while the natural mechanisms of haemostasis are enacted. Once haemostasis is achieved, this device is removed. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10857141005251	GS1
Unit of Use	00857141005254	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 100 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: – 100 Degrees Fahrenheit