Vacuette

Basic Information

• Brand Name: Vacuette
• Primary DI: 19120017577673
• Version / Model: 450097
• Catalog Number: 450097
• Company Name: Greiner Bio-One GmbH
• Labeler DUNS: 303639066
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2020-07-23
• Public Version Status: Update
• Public Device Record Key: c2faa28c-5908-49e7-acba-f59cd57fe459
• Distribution End Date: 2017-10-31

Device Description

SAFETY Blood Collection Set + HOLDEX® 21G x 3/4" tubing length 12" (30 cm), single-packed, sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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

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
Package	39120017577677	GS1		10	Not in Commercial Distribution	2017-10-31
Package	29120017577670	GS1		24	Not in Commercial Distribution	2017-10-31
Primary	19120017577673	GS1

Premarket Submissions

Submission Number	Supplement Number
K011786	000
K080235	000
K121908	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 36 Degrees Celsius