Fertility Control

GUDID 00850212007072

FUJIREBIO US, INC.

Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control Multiple human hormone IVD, control 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

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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.

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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