Mityvac

Basic Information

• Brand Name: Mityvac
• Primary DI: 00888937003147
• Version / Model: 10022
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-07
• Public Version: 5
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: 3b699e1c-0850-40a1-886e-65e08c4292dd

Device Description

Reusable Obstetrical Vacuum Pump

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HDB	Extractor, Vacuum, Fetal	Obstetrics/Gynecology	884.4340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46402	Foetal vacuum extraction system, manual, single-use	An assembly of hand-operated devices designed to facilitate the delivery of a foetus during vaginal childbirth or Caesarean section by enabling traction to be applied to the foetal head by means of a suction cup that is attached to the scalp. It typically consists of a cup with a soft inner liner to prevent tissue damage, a hand-operated pump, and a handle used to apply traction. It is typically used for dystocia, uterine inertia, maternal exhaustion, maternal/foetal distress. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888937003147	GS1

Premarket Submissions

Submission Number	Supplement Number
K980212	000