FDA.reportPublic FDA data

QuickThaw®

Primary DI
00816394020643
Brand
QuickThaw®
Company
HELMER, INC.
Model
DH4
Device description
Plasma Thawing System
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816394020643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816394020643008163940206438163940206430816394020643

GMDN Terms#

Term, Definition table
TermDefinition
Plasma thawing unitA mains electricity (AC-powered) device intended to be used to thaw, in a controlled manner, units of frozen plasma that have been stored, e.g., in the blood bank, prior to use. This device can use a number of methods to achieve this, e.g., microwave oven, heated water bath.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
317-773-9073techservice@helmerinc.com

Regulatory Flags#

DUNS number
086685682
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816394022340Helmer ScientificHBR245-GXC2026-10-14
00816394022357Helmer ScientificiBR245-GXC2026-10-14
00816394022364Helmer ScientificHLR245-GXC2026-10-14
00816394022371Helmer ScientificiLR245-GXC2026-10-14
00816394022388Helmer ScientificHPR245-GXC2026-10-14
00816394022395Helmer ScientificiPR245-GXC2026-10-14
00816394022418Helmer ScientificHBR256-GXC2026-10-14
00816394022425Helmer ScientificiBR256-GXC2026-10-14
00816394022432Helmer ScientificHLR256-GXC2026-10-14
00816394022449Helmer ScientificiLR256-GXC2026-10-14
00816394022456Helmer ScientificHPR256-GXC2026-10-14
00816394022463Helmer ScientificiPR256-GXC2026-10-14
00816394021855Helmer ScientificHPR118-GXC2026-05-13
00816394021916Helmer ScientificHBR118-GXC2026-05-13
00816394021923Helmer ScientificiBR118-GXC2026-05-13
00816394021930Helmer ScientificHLR118-GXC2026-05-13
00816394021947Helmer ScientificiLR118-GXC2026-05-13
00816394021954Helmer ScientificiPR118-GXC2026-05-13
00816394021961Helmer ScientificHBR120-GXC2026-05-13
00816394021978Helmer ScientificiBR120-GXC2026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816394022364Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022371Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022388Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022395Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022432Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022449Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022456Helmer ScientificHELMER, INC.LXG2026-10-14
00816394022463Helmer ScientificHELMER, INC.LXG2026-10-14
04038917124614TUBE SEGMENT OPENER ASM TB 75/12 PSSarstedt Aktiengesellschaft & Co.KGLXG2026-07-21
04038917390835TUBE SEGMENT OPENER ASM TB 75/ 12 PS CBSarstedt Aktiengesellschaft & Co.KGLXG2026-07-21
04038917253437Archiving CapSarstedt Aktiengesellschaft & Co.KGLXG2026-07-20
15099590812478DxUBeckman Coulter, Inc.LXG2026-06-24
08435389828150SAMPLE PREPARATION KITBIOTECHNOLOGY INSTITUTE SLLXG2026-05-27
00816394021855Helmer ScientificHELMER, INC.LXG2026-05-13
15099590695743iChemVELOCITYBECKMAN COULTER IRELAND INC.LXG2026-04-27
09120123910022Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
26974573531033CellproSuzhou CellPro Biotechnology Co., Ltd.LXG2025-11-21
10818207025071Endocator Starter KitVista DentalLXG2025-11-07
10818207025088Endocator Swabs (20pk)Vista DentalLXG2025-11-07
10849832025815Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-23
10849832024238Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
10849832024276Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
10849832027055Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050283KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050306KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050511KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050528KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050535KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050542KBMEDKB Medical (group), Inc.LXG2025-05-22