FDA.reportPublic FDA data

HemoTemp II

Primary DI
M74430001
Brand
HemoTemp II
Company
BIOSYNERGY, INC.
Model
3000
Published
2017-02-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
BK8300060

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK8300060

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M74430002PackageHIBCC5In Commercial Distribution
M74430001PrimaryHIBCC0
M74430000Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-255-5274jaddis@biosynergyinc.com

Regulatory Flags#

DUNS number
070698154
Device count
40
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M74481000HemoCool Gel-Pak810081002018-01-10
M74490000HemoTemp II Activator90002017-06-01
M74420001HemoTemp20002016-09-01
M74450001StaFreez50002017-06-01
M74460001LabTemp 2060002017-06-01
M74420002HemoTemp20002016-09-01
M74450002StaFreez50002017-06-01
M74481001HemoCool Gel-Pak810081002018-01-10
M74490001HemoTemp II Activator90002017-06-01
M74461001LabTemp 4061002017-06-01
M74410004TempTrend10002016-09-01
M74411001TempTrend II11002016-09-01
M74410001TempTrend10002016-09-01
M74460002LabTemp 2060002017-06-01
M74410002TempTrend10002016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10812269031285TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031240Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
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