PARA-AID

GUDID 00819221012002

Pregnancy Test

McUre Health Solutions, Inc.

Foetal/maternal multiple physiological parameter simulation kit

• Primary Device ID: 00819221012002
• NIH Device Record Key: b639ca63-c18f-4466-aa7e-618e58d358d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PARA-AID
• Version Model Number: 0001
• Company DUNS: 053034873
• Company Name: McUre Health Solutions, Inc.
• 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: true
• 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: 6268399001
• Email: yuluw@m-cure.net
• Phone: 6268399001
• Email: yuluw@m-cure.net

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819221012002 [Primary]

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: 2018-03-29
• Device Publish Date: 2016-12-15