CSTP LB 2V GXL BLS

Basic Information

• Brand Name: CSTP LB 2V GXL BLS
• Primary DI: 07290102590063
• Version / Model: Large Bore Closed Stopcock
• Catalog Number: 456063
• Company Name: Elecam Medical Agricultural Cooperative Society Ltd.
• Labeler DUNS: 532599255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-01
• Public Version: 1
• Public Version Date: 2020-06-09
• Public Version Status: New
• Public Device Record Key: 073380bd-3cc6-4900-b9ea-c3315769ec31

Device Description

ULTRAPORT ™ High-Flow 4-Way Stopcock with Dual Valve Port

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: 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
FMG	Stopcock, I.V. Set	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35375	Stopcock	A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290102590060	GS1	Carton box	100	In Commercial Distribution
Primary	07290102590063	GS1
Package	27290102590067	GS1	Shipper	1200	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060231	000
K190489	000

Device Sizes

Type	Value	Unit	Text
Pressure	200	KiloPascal

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 40 Degrees Celsius