Amniocentesis Needle

Basic Information

• Brand Name: Amniocentesis Needle
• Primary DI: 07350025912288
• Version / Model: 14801
• Company Name: Vitrolife Sweden AB
• Labeler DUNS: 631805488
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 4
• Public Version Date: 2019-11-28
• Public Version Status: Update
• Public Device Record Key: 70462c25-995c-4959-811a-c7fc47722f25
• Distribution End Date: 2019-11-27

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
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	Obstetrics/Gynecology	884.1550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44071	Amniocentesis kit, non-medicated	A collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, and dressings. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17350025912285	GS1		10	Not in Commercial Distribution	2019-11-27
Primary	07350025912288	GS1

Premarket Submissions

Submission Number	Supplement Number
K862365	000