Diametrics Medical, Inc.
Roseville, MN, US
Diametrics Medical, Inc. appears in FDA device records in Roseville, MN. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Diametrics Medical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- LifeHealth, LLCenforcement report, recall
510(k) clearance history
FDA records hold 11 510(k) clearances for Diametrics Medical, Inc. between 1995 and 2003. The busiest year on record is 1997, with 3. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 2 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K030035 | IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE | JFY | Substantially Equivalent | |
| K013938 | IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE | KHP | Substantially Equivalent | |
| K011586 | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE | GAA | Substantially Equivalent | |
| K983198 | TRENDCARE CALIBRATOR MODEL SCU 7007 | CCC | Substantially Equivalent | |
| K980380 | NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS | GWM | Substantially Equivalent | |
| K981270 | IRMA BLOOD ANALYSIS SYSTEM | CGZ | Substantially Equivalent | |
| K980523 | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE | CHL | Substantially Equivalent | |
| K972314 | PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM | CCC | Substantially Equivalent | |
| K974396 | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE | CHL | Substantially Equivalent | |
| K970906 | PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR | CBZ | Substantially Equivalent | |
| K945240 | IRMA BLOOD ANALYSIS SYSTEM | CHL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- CCCAnalyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
- CBZAnalyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- GWMDevice, Monitoring, Intracranial Pressure
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CGZElectrode, Ion-Specific, Chloride
- JFYEnzymatic Method, Creatinine
- GAANeedle, Aspiration And Injection, Disposable
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0160-2016 | BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint Blood Analysis System. | May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood. | Class II | Terminated | |
| Z-0159-2016 | CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint Blood Analysis System. | May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood. | Class II | Terminated | |
| Z-1919-2015 | LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl. | The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time. | Class II | Terminated | |
| Z-1072-03 | IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridges, Part Number 039903(M3586A). | An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain