Vacuum Pump Tubing

Basic Information

• Brand Name: Vacuum Pump Tubing
• Primary DI: 17350025914326
• Version / Model: 14211
• Company Name: Vitrolife Sweden AB
• Labeler DUNS: 631805488
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 4
• Public Version Date: 2021-12-07
• Public Version Status: Update
• Public Device Record Key: 1e72ebc4-dc4b-4dd0-b6f2-cb703d061959
• Distribution End Date: 2021-12-06

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
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	884.6100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34923	Suction system catheter, general-purpose	A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17350025914326	GS1
Unit of Use	07350025914329	GS1

Premarket Submissions

Submission Number	Supplement Number
K991273	000