Premom Pregnancy Test Strips (30 Tests) PMS-130

GUDID 10810038632527

Premom Pregnancy Test Strips (30 test per kit)

EASY HEALTHCARE CORPORATION

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10810038632527
• NIH Device Record Key: a95353dd-dd4f-49d5-9ffc-7ec34b537077
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premom Pregnancy Test Strips (30 Tests)
• Version Model Number: PM1-S
• Catalog Number: PMS-130
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810038632520 [Primary]
GS1	10810038632527 [Package]; Contains: 00810038632520; Package: Carton [120 Units]; In Commercial Distribution
GS1	30810038632521 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123703

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, 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: 2022-02-25
• Device Publish Date: 2022-02-17

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