Zacurate M490N-CBAA-EGZA

GUDID 00856964007322

Zacurate Combined Pregnancy Kit - 60 Ovulation strip + 20 Pregnancy strips

EINSTEIN ASSOCIATES LLC

Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00856964007322
• NIH Device Record Key: 8d8f3409-0e77-4222-bc7e-69c2bcbdecaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zacurate
• Version Model Number: M490N-CBAA-EGZA
• Catalog Number: M490N-CBAA-EGZA
• Company DUNS: 080641505
• Company Name: EINSTEIN ASSOCIATES LLC
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 8329398290
• Email: cs@beyondmedshop.com
• Phone: 8329398290
• Email: cs@beyondmedshop.com
• Phone: 8329398290
• Email: cs@beyondmedshop.com
• Phone: 8329398290
• Email: cs@beyondmedshop.com
• Phone: 8329398290
• Email: cs@beyondmedshop.com
• Phone: 8329398290
• Email: cs@beyondmedshop.com
• Phone: 8329398290
• Email: cs@beyondmedshop.com
• Phone: 8329398290
• Email: cs@beyondmedshop.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856964007322 [Primary]

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-30
• Device Publish Date: 2018-06-29

On-Brand Devices [Zacurate]

• 00856964007582: Fingertip Pulse Oximeter (500E)
• 00856964007339: Zacurate Pregnancy Kit - 2pc Wand
• 00856964007322: Zacurate Combined Pregnancy Kit - 60 Ovulation strip + 20 Pregnancy strips
• 00856964007292: Fingertip Pulse Oximeter (500B)
• 00856964007100: Fingertip Pulse Oximeter
• 00856964007094: Fingertip Pulse Oximeter
• 00856964007087: Fingertip Pulse Oximeter
• 00856964007070: Fingertip Pulse Oximeter
• 00856964007063: Fingertip Pulse Oximeter
• 00856964007056: Fingertip Pulse Oximeter
• 00856964007049: Fingertip Pulse Oximeter
• 00856964007032: Fingertip Pulse Oximeter
• 00856964007025: Fingertip Pulse Oximeter (500BL)
• 00856964007018: Fingertip Pulse Oximeter (500E)
• 00856964007001: Fingertip Pulse Oximeter (300A)