JMS HARMONY A.V.FISTULA NEEDLE SET

Basic Information

• Brand Name: JMS HARMONY A.V.FISTULA NEEDLE SET
• Primary DI: 08888483005482
• Version / Model: 827-1503-33
• Company Name: JMS SINGAPORE PTE LTD
• Labeler DUNS: 595159278
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a5c794fb-1200-4eb2-aa66-a4fe4dbd8f54

Device Description

HARMONY A.V.FISTULA 15GX1" BE 40CM W/CLAMP

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: MR Conditional
• 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

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
Primary	08888483005482	GS1
Package	38888483005483	GS1		100	In Commercial Distribution
Package	58888483005487	GS1		2	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	15	Gauge

Storage Conditions

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