FDA.reportPublic FDA data

Boule EasyCleaner

Primary DI
07350040791417
Brand
Boule EasyCleaner
Company
Boule Medical AB
Model
Boule EasyCleaner, 50ml
Catalog number
1504513
Device description
Boule EasyCleaner is an accessory intended for regular cleaning and maintenance of Medonic M51/Swelab Lumi inlet and fluidic system
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JCBDetergent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCBDetergentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350040791417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350040791417073500407914177350040791417

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1800-453-3328qualitygroup@boule.com

Regulatory Flags#

DUNS number
354417933
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350040790687Micro pipette, plastic EDTAMicro pipette, plastic EDTA 1x10010700392024-10-04
07350040790250Micro pipette, plastic EDTAMicro pipette, plastic EDTA 1x10010700392024-10-04
07350040796399Medonic M51-D DiluentMedonic M51-D Diluent, 20L15045102024-10-04
07350040796405Medonic M51-L1 LyseMedonic M51-L1 Lyse, 200mL15045112024-10-04
07350040796412Medonic M51-L2 LyseMedonic M51-L2 Lyse, 500mL15045122024-10-04
07350040796429Swelab Lumi-D DiluentSwelab Lumi-D Diluent 20L15045142024-10-04
07350040796436Swelab Lumi-L1 LyseSwelab Lumi-L1 Lyse 200mL15045152024-10-04
07350040796443Swelab Lumi-L2 LyseSwelab Lumi-L2 Lyse, 500mL15045162024-10-04
07350040796344Medonic M-seriesM16 US14001062016-09-17
07350040796351Medonic M-seriesM16M US140000732016-09-17
07350040796368Medonic M-seriesM16C US14000742016-09-17
07350040796375Medonic M-seriesM16S BD ABR US14000752016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750622Detergent for Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JCB2026-04-16
06935740750639Detergent for Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JCB2026-04-16
06935740750646Detergent for Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JCB2026-04-16
08436583731888Grifols Wash Solution ADIAGNOSTIC GRIFOLS SAJCB2026-03-13
08436583731895Grifols Wash Solution BDIAGNOSTIC GRIFOLS SAJCB2026-03-13
06936415904678MR Detergent SolutionShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-23
06936415904685MR Buffer SolutionShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-23
06936415994457PROBE CLEANSERShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-22
06944904030210PROBE CLEANSERShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-22
159998600941705x TBS Wash BufferDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-12-11
059998600941735x TBS Wash BufferDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-12-11
15999883586751Atellica DT Solution 1 (S1)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
15999883586867Atellica DT Solution 4 (S4)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
45999883586752Atellica DT Solution 2 (S2)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
25999883586758Atellica DT Solution 1 (S1)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
15999883586850Atellica DT Solution 3 (S3)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
25999883586864Atellica DT Solution 4 (S4)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
55999883586759Atellica DT Solution 2 (S2)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
00739470000011Micro-Scientific Enzyclean IIMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000028Micro-Scientific EnzycleanMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000066Micro-Scientific MicroKleen HSMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000158Micro-Scientific Enzyclean II LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000172Micro-Scientific MicroKleen LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470400163Micro-Scientific Enzyclean IVMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000018Micro-Scientific Enzyclean IIMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000025Micro-Scientific EnzycleanMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000063Micro-Scientific MicroKleen HSMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000155Micro-Scientific Enzyclean II LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000179Micro-Scientific MicroKleen LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
50739470400168Micro-Scientific Enzyclean IVMICRO-SCIENTIFIC, LLCJCB2025-04-29