FDA.report

B Medical Systems

Primary DI
05450104533846
Brand
B Medical Systems
Company
B Medical Systems SARL
Model
FR750G
Catalog number
991.7037.55
Device description
Plasma storage freezer
Published
2016-12-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KSERefrigerator, Freezer, Blood Storage

Product Code Classifications

CodeDeviceSpecialtyClass
KSERefrigerator, Freezer, Blood StorageHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05450104533846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05450104533846054501045338465450104533846

GMDN Terms

TermDefinition
Blood plasma freezerAn electrically-powered device intended to be used to store and/or transport blood plasma while keeping it frozen (temperatures of or below -18° Celsius). It typically includes internal shelving for storage and easy location of plasma containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; forced-air circulation and automatic defrost capability; and sensors, controls, monitors, chart recorders (week-long recordings are typical), and alarms (over temperature, under temperature, and power failure).

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
377142935
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 DIBrandModelCatalogPublished
05450104061837B Medical SystemsMT100991.2370.**2022-06-08
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
05450104548291B Medical SystemsL130991.8316.**2020-05-04
05450104548345B Medical SystemsB381991.8336.**2020-05-04
05450104548369B Medical SystemsP380991.8336.**2020-05-04
05450104548383B Medical SystemsLF260991.8346.**2020-05-04
05450104548253B Medical SystemsB51991.8306.**2020-04-17
05450104548260B Medical SystemsL55991.8306.**2020-04-17
05450104548277B Medical SystemsP55991.8306.**2020-04-17
05450104548284B Medical SystemsB131991.8316.**2020-03-04
05450104548307B Medical SystemsP130991.8316.**2020-03-04
05450104548376B Medical SystemsBF261991.8346.**2020-03-04
05450104548390B Medical SystemsPF260991.8346.**2020-03-04
05450104548321B Medical SystemsL290991.8326.**2020-03-02
05450104548352B Medical SystemsL380991.8336.**2020-03-02
05450104493294B Medical SystemsBR250G991.6627.**2020-02-11
05450104493300B Medical SystemsLR250G991.6627.**2020-02-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00761101151861HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151878HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
10885380193316CARDINAL HEALTHCardinal Health 200, LLCKSE2025-04-15
00857117006933FollettFOLLETT CORPORATIONKSE2025-02-04
00857117006940FollettFOLLETT CORPORATIONKSE2025-02-04
06949573500644Haier BiomedicalQingdao Haier Biomedical Co LtdKSE2025-01-07
06949573563625Haier BiomedicalQingdao Haier Biomedical Co LtdKSE2025-01-07
00857117006872FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006889FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006896FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006902FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006919FollettFOLLETT CORPORATIONKSE2024-12-23