Surseal® II

Basic Information

• Brand Name: Surseal® II
• Primary DI: 00607915119904
• Version / Model: SEAL-005
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• Labeler DUNS: 187129135
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 688905c1-b132-4b20-95df-4ac34fcecab6

Device Description

Endoscopic Valve with Adapter.

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: 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
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35511	Vascular catheter flush valve, continuous	A specialized, sterile, Y-piece device intended to be connected in an infusion line to an indwelling catheter and provide for the connection of a second infusion source. The second source usually serves to maintain a low keep vein open (KVO) flow in the catheter to prevent clotting. This device (the flush valve) may be equipped with a manually-operated mechanism to permit flushing of the line at a free-flow rate. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10607915119901	GS1		10	In Commercial Distribution
Primary	00607915119904	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0-5F