Safe-T-Vue 10

Basic Information

• Brand Name: Safe-T-Vue 10
• Primary DI: 10852282007140
• Version / Model: STV10
• Catalog Number: 7201-50
• Company Name: Temptime Corporation
• Labeler DUNS: 152578522
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2019-10-29
• Public Version: 1
• Public Version Date: 2019-11-06
• Public Version Status: New
• Public Device Record Key: c955e39b-88e2-4eb0-9216-7c2092225291

Device Description

A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSS	Supplies, Blood-Bank	Hematology	864.9050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60964	Medical product temperature point indicator, thermochemical	A small device intended to be attached to a bag containing a temperature-sensitive medical product (e.g., blood, pharmaceutical) to indicate, by non-reversible chemical colour change, when a predetermined temperature is reached and exceeded, potentially making the product non-viable. It typically consists of a self-adhesive plastic container that holds a patch of heat-sensitive material which is activated when the container is attached to the product of interest. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20852282007147	GS1	Case of 200	4	In Commercial Distribution
Primary	10852282007140	GS1
Unit of Use	00852282007143	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
BK910005	0

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Refrigerate at the same temperature as the blood for a minimum of 24 hours prior to use.
• Type: Storage Environment Temperature
• Temperature Range: 1 – 25 Degrees Celsius