FDA.reportPublic FDA data

DPM1B

Primary DI
00850540007188
Brand
DPM1B
Company
FLUKE ELECTRONICS CORPORATION
Model
DPM1B
Catalog number
2249779
Device description
Pneumatic Transducer Tester
Published
2018-05-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DRSTransducer, Blood-Pressure, Extravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K862344000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862344000GOULD XCALIBERBio-Tek Instruments, Inc.1986-08-06DRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850540007188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850540007188008505400071888505400071880850540007188

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002687614
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850540007133Impulse 4000IMPULSE4K-USA120V22471572018-05-24
00850540007157SigmaPace 1000SIGMAP1K-USA120V22477002018-05-24
00850540007225ProSim 8PPROSIM 8P60217062025-05-07
00850540007195BP Pump 2LBPPUMP2L-US120V22490362018-05-24
00850540007201BP Pump 2MBPPUMP2M-US120V22490492018-05-24
00850540007218ESA 614ESA61450319182019-04-04
00850540007065ProSim 8PROSIM 839794092018-05-24
00850540007072ProSim 4PROSIM 439851562018-05-24
00850540007089ProSim 2PROSIM 243183412018-05-24
00850540007096ProSim 3PROSIM 343077902018-05-24
00850540007102ProSim SPOT LightSPOT LIGHT41111012018-05-24
00850540007119Impulse 6000DIMPULSE 6000D28119282018-05-24
00850540007140Impulse 7010IMPULSE 701031585442018-05-24
00850540007164PS320PS32025830302018-05-24
00850540007171PS410PS41026312762018-05-24
00850540007010ESA 620ESA62027857252018-05-24
00850540007027ESA 615ESA615-US41320462018-05-24
00850540007034ESA 615ESA615-10-NA22041321642018-05-24
00850540007041ESA 612ESA612-US41321732018-05-24
00850540007058ESA 612ESA612-10-NA22041322602018-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403530695Acumen IQBecton, Dickinson And CompanyDRS2026-09-04
00885403531715FloTrac JrBecton, Dickinson And CompanyDRS2026-09-04
00885403531722Acumen IQBecton, Dickinson And CompanyDRS2026-09-04
00885403531814FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531821FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531913FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531920FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531937FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531845FLOTRAC, VAMPBecton, Dickinson And CompanyDRS2026-07-31
00885403541974FLOTRAC, VAMPBecton, Dickinson And CompanyDRS2026-07-31
00885403531654Acumen IQBecton, Dickinson And CompanyDRS2026-05-30
00885403531678Acumen IQ, VAMPBecton, Dickinson And CompanyDRS2026-05-30
00885403531739Acumen IQBecton, Dickinson And CompanyDRS2026-05-30
08886483502390BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503151BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503748ACCUTRANS Disposable Pressure Monitoring KitBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483507005BIOTRANS™ Reusable Sensor Base and Monitor Adapter CablesBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
00887709089785ICU MedicalICU MEDICAL, INC.DRS2021-08-29
06945764400403AntmedShenZhen Antmed Co., LtdDRS2017-08-24
06945764404135AntmedShenZhen Antmed Co., LtdDRS2017-08-24
H6713000060N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000120N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000180N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000240N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000360N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000480N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000600N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000720N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000840N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100060N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23