Safe-T-Vue 10

Primary DI
20852282007147
Brand
Safe-T-Vue 10
Company
Temptime Corporation
Model
STV10
Catalog number
7201-50
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.
Published
2019-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSSSupplies, Blood-Bank

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSSSupplies, Blood-BankHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK9100050

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK9100050

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20852282007147PackageGS14In Commercial Distribution
10852282007140PrimaryGS10
00852282007143Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085228200714720852282007147
1085228200714010852282007140
00852282007143008522820071438522820071430852282007143

GMDN Terms#

Term, Definition table
TermDefinition
Medical product temperature point indicator, thermochemicalA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
973-630-6000info@temptimecorp.com

Regulatory Flags#

DUNS number
152578522
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10852282007140Safe-T-Vue 10STV107201-502019-10-29
10852282007157Safe-T-Vue 6STV67206-502019-10-29
00852282007006HEATmarker® Time-Temperature Indicators: F3F32016-09-23
00852282007013HEATmarker® Time-Temperature Indicators: F6F62016-09-23
00852282007020HEATmarker® Time-Temperature Indicators: F9F92016-09-23
00852282007037HEATmarker® Time-Temperature Indicators: F12F122016-09-23
00852282007044HEATmarker® Time-Temperature Indicators: F24F242016-09-23
00852282007051HEATmarker® Time-Temperature Indicators: F36F362016-09-23
00852282007068HEATmarker® Time-Temperature Indicators: CT2CT22016-09-23
00852282007075HEATmarker® Time-Temperature Indicators: CT3CT32016-09-23
00852282007082HEATmarker® Time-Temperature Indicators: CT4CT42016-09-23
00852282007099HEATmarker® Time-Temperature Indicators: CT6CT62016-09-23
00852282007105HEATmarker® Time-Temperature Indicators: CT9CT92016-09-23
00852282007112HEATmarker® Time-Temperature Indicators: CT24CT242016-09-23
00852282007129HEATmarker® Time-Temperature Indicators: CT12CT122016-09-23
00852282007136HEATmarker® Time-Temperature Indicators: CT36CT362016-09-23

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