Pregmate 50 Ovulation and 20 Pregnancy Test Strips

GUDID 00850009763266

Pregmate LLC

Total human chorionic gonadotropin (HCG) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00850009763266
• NIH Device Record Key: 52f047f3-6db0-446c-a588-173f161b0f58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pregmate 50 Ovulation and 20 Pregnancy Test Strips
• Version Model Number: 50LH20HCG
• Company DUNS: 071197287
• Company Name: Pregmate LLC
• Device Count: 70
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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	00850009763136 [Primary]
GS1	00850009763143 [Primary]
GS1	00850009763150 [Primary]
GS1	00850009763266 [Unit of Use]
GS1	00850009763273 [Primary]
GS1	00850009763280 [Primary]
GS1	00857747008932 [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: 2023-04-11
• Device Publish Date: 2023-04-03

Devices Manufactured by Pregmate LLC

• 00850009763259 - Pregmate Pregnancy Test Strips (50 Count): 2023-08-24
• 00850009763266 - Pregmate 50 Ovulation and 20 Pregnancy Test Strips: 2023-04-11
• 00850009763266 - Pregmate 50 Ovulation and 20 Pregnancy Test Strips: 2023-04-11
• 00850009763167 - Pregmate Pregnancy Test Strips (50 Count): 2023-04-11