Gentle Vac

Basic Information

• Brand Name: Gentle Vac
• Primary DI: 10861372000305
• Version / Model: 17420
• Company Name: Axcesor, Inc.
• Labeler DUNS: 066864224
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-03-20
• Public Version: 7
• Public Version Date: 2023-07-03
• Public Version Status: Update
• Public Device Record Key: 322c6227-ae3a-4508-8a1e-9ef216cd1d5d
• Distribution End Date: 2023-07-01

Device Description

Vacuum Assist Cup 60mm, 10 pack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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
32596	Foetal vacuum extraction system cup, reusable	A suction cap intended to be applied to the scalp of a foetus to facilitate vaginal or Caesarean section delivery by traction. It typically has a soft liner to prevent tissue damage, a connection to the vacuum source, a handgrip for the clinician to apply traction, and may include a vacuum release valve and fluid retention trap. Suction may be provided by an electrically-powered suction pump, the hospital central vacuum system, or a hand-operated vacuum pump. It is typically used for dystocia, uterine inertia, maternal exhaustion, or maternal/foetal distress. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10861372000305	GS1
Unit of Use	00861372000308	GS1

Customer Contacts

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