FDA.reportPublic FDA data

HemoTemp

Primary DI
20815236021057
Brand
HemoTemp
Company
LCR HALLCREST, LLC.
Model
2000
Device description
Blood Bag Temperature Monitor
Published
2022-06-20
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
KSERefrigerator, Freezer, Blood Storage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSERefrigerator, Freezer, Blood StorageHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20815236021057PackageGS15In Commercial Distribution
M74420001PreviousHIBCC0
10815236021050PrimaryGS10
00815236021053Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081523602105720815236021057
1081523602105010815236021050
00815236021053008152360210538152360210530815236021053

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
40
DM exempt
false
Premarket exempt
true
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
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
20815236020197Crystaline® Moving Line5101SD-MLC5101SD-MLC2022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816394021916Helmer ScientificHELMER, INC.KSE2026-05-13
00816394021923Helmer ScientificHELMER, INC.KSE2026-05-13
00816394021961Helmer ScientificHELMER, INC.KSE2026-05-13
00816394021978Helmer ScientificHELMER, INC.KSE2026-05-13
00816394022036Helmer ScientificHELMER, INC.KSE2026-05-13
00816394022043Helmer ScientificHELMER, INC.KSE2026-05-13
00818630019053BRIDGE™ FRIDGE RefrigeratorTACTICAL MEDICAL SOLUTIONS, LLCKSE2026-05-05
00818630019008Expeditionary Refrigerator (xFRIDGE™)TACTICAL MEDICAL SOLUTIONS, LLCKSE2026-04-24
10816934023087Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature FreezerKEY SCIENTIFIC INCKSE2026-04-10
10816934023094Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature FreezerKEY SCIENTIFIC INCKSE2026-04-10
10816934023100Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature FreezerKEY SCIENTIFIC INCKSE2026-04-10
10816934023117Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature FreezerKEY SCIENTIFIC INCKSE2026-04-10
04260688580331KirschPhilipp Kirsch GmbHKSE2026-03-04
04260688580348KirschPhilipp Kirsch GmbHKSE2026-03-04
04260688580317KirschPhilipp Kirsch GmbHKSE2026-02-23
04260688580324KirschPhilipp Kirsch GmbHKSE2026-02-23
00857117006957FollettFOLLETT CORPORATIONKSE2026-01-13
00857117006964FollettFOLLETT CORPORATIONKSE2026-01-13
00860015036803Expeditionary RefrigeratorTACTICAL MEDICAL SOLUTIONS, LLCKSE2026-01-07
00761101151694HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151700HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151717HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151786HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151793HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151809HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151816HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151823HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151830HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151847HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151854HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20