JMS Sysloc A.V. Fistula Needle Set

Basic Information

• Brand Name: JMS Sysloc A.V. Fistula Needle Set
• Primary DI: 08888483006113
• Version / Model: 824-1704
• Company Name: JMS SINGAPORE PTE LTD
• Labeler DUNS: 595159278
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-04
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 57dd5da9-a61c-486d-aa59-d9e5a90f0b6d

Device Description

SYSLOC AVF 17GX1" BE 15CM W/CLAMP HAE-L/N 03016-17

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: Yes
• 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
FIE	Needle, Fistula	Gastroenterology, Urology	876.5540	2
FOZ	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12741	Haemodialysis needle	A sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	38888483006114	GS1	Inner Box	50	In Commercial Distribution
Primary	08888483006113	GS1
Package	58888483006118	GS1	Outer Box	10	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	17	Gauge

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius