FDA.reportPublic FDA data

Helmer Scientific

Primary DI
00816394022388
Brand
Helmer Scientific
Company
HELMER, INC.
Model
HPR245-GXC
Device description
Pharmacy Refrigerator, 45 cu ft
Published
2026-10-14
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
false

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
00816394022388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816394022388008163940223888163940223880816394022388

GMDN Terms#

Term, Definition table
TermDefinition
Pharmacy refrigeratorA mains electricity (AC-powered) refrigerator specially designed for cool storage of pharmaceuticals, e.g., medications or live virus vaccines. It may be provided with a built-in alarm system that warns against unexpected temperature variations.

Regulatory Flags#

DUNS number
086685682
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
00816394022340Helmer ScientificHBR245-GXC2026-10-14
00816394022357Helmer ScientificiBR245-GXC2026-10-14
00816394022364Helmer ScientificHLR245-GXC2026-10-14
00816394022371Helmer ScientificiLR245-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
00816394021985Helmer ScientificHLR120-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
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
00816394021930Helmer 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