FDA.reportPublic FDA data

HemoTemp II

Primary DI
10815236021067
Brand
HemoTemp II
Company
LCR HALLCREST, LLC.
Model
HemoTemp II
Published
2022-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815236021067PackageGS140In Commercial Distribution
20815236021064PackageGS15In Commercial Distribution
M74430001PreviousHIBCC0
00815236021060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081523602106710815236021067
2081523602106420815236021064
00815236021060008152360210608152360210600815236021060

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
847-998-8580orders@hallcrest.com

Regulatory Flags#

DUNS number
059247507
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
10815236020671FeverScanBB150BB1502016-09-24
10815236020695FeverScanBB150BB1502016-09-24
00815236020926HemoTemp II Activator90002022-06-16
10815236021050HemoTemp20002022-06-20
10815236021074TempTrend II11002022-06-20
10815236021104StaFreez50002022-06-20
10815236021135LabTemp 4061002022-06-20
20815236021057HemoTemp20002022-06-20
20815236021071TempTrend II11002022-06-20
20815236021101StaFreez50002022-06-20
20815236021132LabTemp 4061002022-06-20
10815236021128LabTemp 2060002022-06-16
10815236020923HemoTemp II Activator90002022-06-16
20815236021125LabTemp 2060002022-06-16
10815236020176Crystaline® Moving Line5101C-MLC5101C-MLC2022-03-01
10815236020183Crystaline® Moving Line5101H-MLC5101H-MLC2022-03-01
10815236020190Crystaline® Moving Line5101SD-MLC5101SD-MLC2022-03-01
10815236020206Crystaline® Moving Line5101SB-MLC5101SB-MLC2022-03-01
20815236020173Crystaline® Moving Line5101C-MLC5101C-MLC2022-03-01
20815236020180Crystaline® Moving Line5101H-MLC5101H-MLC2022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540151300121RadTagRadtag Technologies IncKSS2025-12-30
07540151300138RadTagRadtag Technologies IncKSS2025-12-30
07540151300145RadTagRadtag Technologies IncKSS2025-12-30
07540151300152RadTagRadtag Technologies IncKSS2025-12-30
05060242472596ORTHO® Elution KitALBA BIOSCIENCE LIMITEDKSS2025-12-04
09555240405616SampLok® Sampling Kit 16mLITL ASIA PACIFIC SDN. BHD.KSS2025-06-04
19555240405613SampLok® Sampling Kit 16mLITL ASIA PACIFIC SDN. BHD.KSS2025-06-04
07540151300107AccuTagRadtag Technologies IncKSS2023-11-02
05060242477959ALBA Elution KitALBA BIOSCIENCE LIMITEDKSS2023-10-13
00810106410333Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-05-10
00810106410340Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-05-10
00810106410326Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-04-24
07540151300046RadTagRadtag Technologies IncKSS2022-12-02
07540151300053RadTagRadtag Technologies IncKSS2022-12-02
07540151300060RadTagRadtag Technologies IncKSS2022-12-02
07540151300077RadTagRadtag Technologies IncKSS2022-12-02
07540151300008RadTagRadtag Technologies IncKSS2022-12-01
07540151300015RadTagRadtag Technologies IncKSS2022-12-01
07540151300022RadTagRadtag Technologies IncKSS2022-12-01
07540151300039RadTagRadtag Technologies IncKSS2022-12-01
10812269031230Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
10812269031254Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
10812269031278TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
10812269031285TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031240Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
00812269031264Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
20812269031275TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031295TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
10810020440536Hematype Segment DeviceFresenius Kabi AGKSS2022-11-08
20810020440533Hematype Segment DeviceFresenius Kabi AGKSS2022-11-08