Fertility Control

GUDID 00850212007072

FUJIREBIO US, INC.

Multiple human hormone IVD, control

• Primary Device ID: 00850212007072
• NIH Device Record Key: 1c6d8c0e-a1b3-47ad-9add-bccffac1d2c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fertility Control
• Version Model Number: 2130162
• Company DUNS: 029385775
• Company Name: FUJIREBIO US, 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: true
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com
• Phone: 800-531-7963
• Email: customerservice@fdi.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850212007072 [Primary]

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: 2019-11-12
• Device Publish Date: 2019-11-04

Devices Manufactured by FUJIREBIO US, INC.

• 00850212007096 - Lumipulse G Wash Solution: 2020-02-07 Lumipulse G Wash Solution
• 00850212007072 - Fertility Control: 2019-11-12
• 00850212007072 - Fertility Control: 2019-11-12
• 00850212007089 - Vitamin D Control: 2019-11-12
• 00850212007010 - Serodia TP-PA: 2018-07-06 100 test kit
• 00850212007027 - Serodia TP-PA: 2018-07-06 220 test kit
• 00850212007034 - Vitamin D Control: 2018-07-06
• 00850212007041 - Beckman Coulter PK TP System Control Set: 2018-07-06
• 00850212007058 - Beckman Coulter PK CMV-PA SYSTEM Control Set: 2018-07-06