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 Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

• 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)