FDA.reportPublic FDA data

Transonic

Primary DI
00877466001809
Brand
Transonic
Company
TRANSONIC SYSTEMS INC.
Model
HQD8FME
Published
2020-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DPWFlowmeter, Blood, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872048000TRANSONIC FLOWMETERTransonic Systems, Inc.1988-06-21DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877466001809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877466001809008774660018098774660018090877466001809

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic profile clinical chemistry analyser IVD, portable, automatedA portable mains electricity (AC-powered) laboratory instrument, typically with rechargeable batteries for power at the point-of-care in acute care settings, intended used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., Sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with minimal technician involvement and automation of all procedural steps.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
101317451
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00877466000437TransonicHD032020-10-01
00877466002141TransonicHQD3FMV2020-10-08
00877466001182TransonicHQD24AU2020-10-08
00877466001762TransonicHQD2FME2020-10-08
00877466001779TransonicHQD3FME2020-10-08
00877466001786TransonicHQD4FME2020-10-08
08774660000244TransonicADT1001-102016-04-28
08774660000251TransonicADT1002-102016-04-28
08774660000268TransonicADT1004-102016-04-28
08774660000336TransonicHCS3011-52016-04-28
08774660000343TransonicHCS3012-52016-04-28
08774660000350TransonicHCS3021-52016-04-28
08774660000367TransonicHCS3002-52016-04-28
08774660000466TransonicADT1010-402016-04-28
08774660000473TransonicADT1018-402016-04-28
08774660001425TransonicH8AUL-52016-04-28
08774660001432TransonicH10AUL-52016-04-28
08774660001449TransonicH12AUL-52016-04-28
08774660001456TransonicH14AUL-52016-04-28
08774660001463TransonicH16AUL-52016-04-28

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Primary DI, Brand, Company table
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10627987360148Dual Adhesive Strap1929803 Ontario CorpDPW2023-03-03
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