Amniocentesis Tray

Basic Information

• Brand Name: Amniocentesis Tray
• Primary DI: 00886333220793
• Version / Model: A4545A
• Catalog Number: A4545A
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-20
• Public Version: 1
• Public Version Date: 2022-07-28
• Public Version Status: New
• Public Device Record Key: 269337c8-b70e-43ef-8dc1-40992d0551bb

Device Description

Amniocentesis Tray with 20ga x 8.9cm Needle

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
35496	Amniocentesis kit, medicated, single-use	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, dressings, and pharmaceuticals. 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	20886333220797	GS1	Box	10	In Commercial Distribution
Primary	00886333220793	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20ga x 8.9cm