FDA.reportPublic FDA data

B Medical Systems

Primary DI
05450104548321
Brand
B Medical Systems
Company
B Medical Systems SARL
Model
L290
Catalog number
991.8326.**
Device description
Laboratory refrigerator
Published
2020-03-02
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
05450104548321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05450104548321054501045483215450104548321

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory refrigerator, basicA mains electricity (AC-powered) refrigerator specially designed to maintain the cold temperatures required for the storage of samples, specimens, cultures, and other laboratory preparations. It will typically have a corrosion resistant (e.g., stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; include a glass door and internal shelving for easy set-up of instrumentation and chromatography devices within the chamber. It will typically include sensors, controls and monitors, forced-air circulation and a built-in alarm system that warns against unexpected temperature variations as well as a recorder to record events.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
377142935
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
05450104061837B Medical SystemsMT100991.2370.**2022-06-08
05450104548390B Medical SystemsPF260991.8346.**2020-03-04
05450104519161B Medical SystemsMP380CS991.6789.**2020-02-11
05450104537721B Medical SystemsPF260991.8346.032018-09-27
05450104532450B Medical SystemsMP380CS991.6789.522018-09-27
05450104548031B Medical SystemsCSF61S991.8936.**2021-07-09
05450104540875B Medical SystemsCSF61S991.8926.**2021-07-01
05450104537929B Medical SystemsCSF61L991.8906.**2021-06-18
05450104551512B Medical SystemsU201991.8643.**2021-05-03
05450104548314B Medical SystemsB291991.8326.**2020-06-17
05450104548338B Medical SystemsP290991.8326.**2020-06-17
05450104548345B Medical SystemsB381991.8336.**2020-05-04
05450104548253B Medical SystemsB51991.8306.**2020-04-17
05450104548284B Medical SystemsB131991.8316.**2020-03-04
05450104493294B Medical SystemsBR250G991.6627.**2020-02-11
05450104494284B Medical SystemsBR410G991.6637.**2020-02-11
05450104495540B Medical SystemsBR490G991.6647.**2020-02-11
05450104496400B Medical SystemsBR750G991.6657.**2020-02-11
05450104513060B Medical SystemsBR110G991.6617.**2020-02-11
05450104532122B Medical SystemsBR110G991.6617.512016-10-17

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
00816394021824FarrarHELMER, INC.JRM2025-01-10
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
05450104548352B Medical SystemsB Medical Systems SARLJRM2020-03-02
05450104493300B Medical SystemsB Medical Systems SARLJRM2020-02-11
05450104493317B Medical SystemsB Medical Systems SARLJRM2020-02-11