Amazon

GUDID 10195515045909

Amazon Basic Care TPS ER

AMAZON.COM SERVICES LLC

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 10195515045909
• NIH Device Record Key: b30d61e8-65b2-43e7-8c01-3404d3fc9401
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amazon
• Version Model Number: Early Result Pregnancy Test
• Company DUNS: 128990418
• Company Name: AMAZON.COM SERVICES LLC
• Device Count: 3
• 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

Customer Support Contacts

• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195515045902 [Primary]
GS1	00633472000126 [Unit of Use]
GS1	10195515045909 [Package]; Contains: 00195515045902; Package: Shipping case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042280

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: 2025-05-28
• Device Publish Date: 2025-05-20

On-Brand Devices [Amazon]

• 10195515050095: Amazon Basic Care DPS DIG Blue
• 10195515045909: Amazon Basic Care TPS ER