Blastocyst Thaw Media Kit 90110

GUDID 00893727002798

Blastocyst Thaw Media Kit

FUJIFILM IRVINE SCIENTIFIC, INC.

IVF medium kit

Primary Device ID	00893727002798
NIH Device Record Key	d8aeb1b9-103c-4c76-a2a9-05b15e40a135
Commercial Distribution Discontinuation	2021-06-09
Commercial Distribution Status	In Commercial Distribution
Brand Name	Blastocyst Thaw Media Kit
Version Model Number	90110-6X10ML
Catalog Number	90110
Company DUNS	057475246
Company Name	FUJIFILM IRVINE SCIENTIFIC, 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	true
Single Use	false
Lot Batch	true
Serial Number	true
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	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com
Phone	8004375706
Email	tmrequest@irvinesci.com

Device Dimensions

Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter
Total Volume	10 Milliliter

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893727002798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K000309

FDA Product Code

MQL	Media, Reproductive

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2021-03-10
Device Publish Date	2016-09-10

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