Natural Cycles

GUDID 07350014630155

Test, Pregnancy, Hcg, Over The Counter

Naturalcycles Nordic AB

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

• Primary Device ID: 07350014630155
• NIH Device Record Key: d21f2c05-eee3-42d7-8d72-f0c17d970dac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natural Cycles
• Version Model Number: 15
• Company DUNS: 352550104
• Company Name: Naturalcycles Nordic AB
• Device Count: 1
• 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	07350014630155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043443

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-10-31
• Device Publish Date: 2019-09-01

On-Brand Devices [Natural Cycles]

• 07350014630131: Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subs
• 07350014630124: B
• 07350014630209: Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermometer, 10 ovulation
• 07350014630148: Test, Luteinizing Hormone (Lh), Over The Counter
• 07350014630155: Test, Pregnancy, Hcg, Over The Counter
• 04719003114114: MT16W2