FDA.reportPublic FDA data

Farrar

Primary DI
00816394021824
Brand
Farrar
Company
HELMER, INC.
Model
FCF133
Device description
Ultralow temperature freezer
Published
2025-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JRMFreezer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRMFreezerClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816394021824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816394021824008163940218248163940218240816394021824

GMDN Terms#

Term, Definition table
TermDefinition
Ultralow-temperature laboratory freezerA mains electricity (AC-powered) freezer designed for the storage of laboratory products and sample materials, e.g., in vitro diagnostic (IVD) reagents and laboratory tissue/body fluid samples that require extremely low temperatures, usually in the range from -40 to -90? Celsius. It will typically have a corrosion resistant (typically stainless steel) interior minimizing the risk of adulteration, contamination, and/or corrosion of the contents and a shelving configuration appropriate for storage/easy localization of the products. It will typically be programmable, have defrost capabilities, a built-in alarm system to warn against temperature variations, and a recorder to record events.

Sterilization Methods#

Method table
Method

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
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
00816394021992Helmer ScientificiLR120-GXC2026-05-13
00816394022005Helmer ScientificHPR120-GXC2026-05-13
00816394022012Helmer ScientificiPR120-GXC2026-05-13
00816394022036Helmer ScientificHBR125-GXC2026-05-13
00816394022043Helmer ScientificiBR125-GXC2026-05-13
00816394022050Helmer ScientificHLR125-GXC2026-05-13
00816394022067Helmer ScientificiLR125-GXC2026-05-13
00816394022074Helmer ScientificHPR125-GXC2026-05-13
00816394022081Helmer ScientificiPR125-GXC2026-05-13
00816394021640HelmeriUF126-GX2019-01-31
00816394021619FARRARFUF1262019-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06949573502594Haier BiomedicalQingdao Haier Biomedical Co LtdJRM2026-01-05
06949573501702Haier BiomedicalQingdao Haier Biomedical Co LtdJRM2025-10-09
06949573500460HaierQingdao Haier Biomedical Co LtdJRM2025-01-23
06949573501443HaierQingdao Haier Biomedical Co LtdJRM2025-01-23
06949573501450HaierQingdao Haier Biomedical Co LtdJRM2025-01-23
06949573525067HaierQingdao Haier Biomedical Co LtdJRM2023-04-12
06949573525074HaierQingdao Haier Biomedical Co LtdJRM2023-04-12
06949573547717HaierQingdao Haier Biomedical Co LtdJRM2023-04-12
06949573548516HaierQingdao Haier Biomedical Co LtdJRM2023-04-12
06949573555231HaierQingdao Haier Biomedical Co LtdJRM2023-04-12
06949573525623HaierQingdao Haier Biomedical Co LtdJRM2023-04-07
03661532003067CBS INTEGRAL FREEZERCRYO BIO SYSTEMJRM2020-10-30
10885380171109CARDINAL HEALTHCardinal Health 200, LLCJRM2020-06-21
10885380171116CARDINAL HEALTHCardinal Health 200, LLCJRM2020-06-21
10885380171147CARDINAL HEALTHCardinal Health 200, LLCJRM2020-06-21
10885380171154CARDINAL HEALTHCardinal Health 200, LLCJRM2020-06-21
05450104548338B Medical SystemsB Medical Systems SARLJRM2020-06-17
05450104548291B Medical SystemsB Medical Systems SARLJRM2020-05-04
05450104548369B Medical SystemsB Medical Systems SARLJRM2020-05-04
05450104548383B Medical SystemsB Medical Systems SARLJRM2020-05-04
05450104548260B Medical SystemsB Medical Systems SARLJRM2020-04-17
05450104548277B Medical SystemsB Medical Systems SARLJRM2020-04-17
10885380164545CARDINAL HEALTHCardinal Health 200, LLCJRM2020-03-18
10885380164552CARDINAL HEALTHCardinal Health 200, LLCJRM2020-03-18
05450104548307B Medical SystemsB Medical Systems SARLJRM2020-03-04
05450104548390B Medical SystemsB Medical Systems SARLJRM2020-03-04
05450104548321B Medical SystemsB Medical Systems SARLJRM2020-03-02
05450104548352B Medical SystemsB Medical Systems SARLJRM2020-03-02
05450104493300B Medical SystemsB Medical Systems SARLJRM2020-02-11
05450104493317B Medical SystemsB Medical Systems SARLJRM2020-02-11