Introducer set with hemostatic valve

Basic Information

• Brand Name: Introducer set with hemostatic valve
• Primary DI: 40888277000705
• Version / Model: DYNJINTROR5
• Catalog Number: DYNJINTROR5
• Company Name: Oscor Inc.
• Labeler DUNS: 101835833
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-11-28
• Public Version: 5
• Public Version Date: 2021-09-13
• Public Version Status: Update
• Public Device Record Key: eec08a31-8f20-48b6-97e6-d3d759afd5cf
• Distribution End Date: 2019-07-30

Device Description

Introducer set with hemostatic valve, 5F

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
DYB	INTRODUCER, CATHETER	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	40888277000705	GS1
Unit of Use	00888277000707	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130633	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Guidewire Length: 45 cm, OD: 0.018 in
Device Size Text, specify			Dilator Length 15 cm
Lumen/Inner Diameter	1.9	Millimeter
Device Size Text, specify			Syringe 10 cc
Device Size Text, specify			Sheath Length 10 cm
Device Size Text, specify			Needle 21 G, 4 cm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius