Amniocentesis Tray A4545ASP

GUDID 20886333220803

Amniocentesis Tray with Safety Devices and 20ga x 8.9cm Needle

ARGON MEDICAL DEVICES, INC.

Amniocentesis kit, medicated, single-use Amniocentesis kit, medicated, single-use Amniocentesis kit, medicated, single-use Amniocentesis kit, medicated, single-use Amniocentesis kit, medicated, single-use Amniocentesis kit, medicated, single-use Amniocentesis kit, medicated, single-use Amniocentesis kit, medicated, single-use Amniocentesis kit, medicated, single-use Amniocentesis kit, medicated, single-use

• Primary Device ID: 20886333220803
• NIH Device Record Key: d0215a5d-d250-4f9c-b491-0115e35e4d3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amniocentesis Tray
• Version Model Number: A4545ASP
• Catalog Number: A4545ASP
• Company DUNS: 140727624
• Company Name: ARGON MEDICAL DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333220809 [Primary]
GS1	20886333220803 [Package]; Contains: 00886333220809; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• HIO: Sampler, Amniotic Fluid (Amniocentesis Tray)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-28
• Device Publish Date: 2022-07-20

On-Brand Devices [Amniocentesis Tray]

• 20886333224306: Amniocentesis Tray with 20ga x 8.9cm Needle without Lidocaine
• 20886333220803: Amniocentesis Tray with Safety Devices and 20ga x 8.9cm Needle
• 20886333220797: Amniocentesis Tray with 20ga x 8.9cm Needle