UNOLOK

Basic Information

• Brand Name: UNOLOK
• Primary DI: 08903347003241
• Version / Model: 19 G X ¾"
• Catalog Number: 00324
• Company Name: HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
• Labeler DUNS: 862318107
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-26
• Public Version: 5
• Public Version Date: 2020-07-23
• Public Version Status: Update
• Public Device Record Key: 59ee0172-7cff-479c-9497-004fc7f13c0c

Device Description

UNOLOK Luer Lock Infusion Set,19 G X ¾" ( 1.10X19MM) 12" TUBE MYCO RE-ORDER # 7001-19

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
FOZ	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58490	Venous butterfly needle/set	An invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08903347003241	GS1
Package	18903347003248	GS1	BOX	100	In Commercial Distribution
Package	28903347003245	GS1	CARTON	10	In Commercial Distribution
Package	58903347003246	GS1	PALLET	18	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K953252	000