AccessGUDID - DEVICE: Safe-T-Vue 10 (10852282007140)

GUDID

Device Identifier (DI) Information

Brand Name: Safe-T-Vue 10
Version or Model: STV10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7201-50
Company Name: Temptime Corporation

Primary DI Number: 10852282007140
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 152578522 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSS	Supplies, Blood-Bank

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK910005	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Refrigerate at the same temperature as the blood for a minimum of 24 hours prior to use.
Storage Environment Temperature: between 1 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c955e39b-88e2-4eb0-9216-7c2092225291
Public Version Date: November 06, 2019
Public Version Number: 1
DI Record Publish Date: October 29, 2019