NIPRO SafeTouch™ Safety Scalp Vein Set

Basic Information

• Brand Name: NIPRO SafeTouch™ Safety Scalp Vein Set
• Primary DI: 00383790002585
• Version / Model: SPR+19G19
• Company Name: NIPRO MEDICAL CORPORATION
• Labeler DUNS: 797372554
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1e97ad73-ccb3-44e4-b053-d03027068c51

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
FMI	Needle, hypodermic, single lumen	General Hospital	880.5570	2
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35211	Scalp vein needle	A very slender, sterile, sharp bevel-edged, hollow tubular metal instrument designed for use on the veins of the scalp or other small veins, especially in paediatric patients. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40383790002583	GS1		10	In Commercial Distribution
Package	10383790002582	GS1		50	In Commercial Distribution
Primary	00383790002585	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			NeedleLength : 3/4 Inch
Device Size Text, specify			Needle Gauge : 19 Gauge
Device Size Text, specify			Tubing Length : 12 Inch