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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Needle Guide - 00841436100366

Reusable non-sterile needle guide with cleaning brushes (5) for use with Siemens BP9-4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10563772
In Commercial Distribution

  • 00841436100366 ()
  • 20841436114695 ()

  • Length: 4.46 Inch
  • Height: 1.31 Inch
10563772

  • Needle guide, reusable

IPPS™ Couchtop - 00841439105283

One piece couchtop with Lok-Bar™ for use with Siemens TXT or Proutra™
MEDTEC, INC.
MTIL6020
In Commercial Distribution

  • 00841439105283 ()
MTIL6020

  • Indexed-immobilization patient positioning system

TIDIShield - 01618125140137

TIDIShield Urology Drain Bags Frosty Vinyl Sterile Fits Siemens Uroskop Access 20 per Case
TIDI PRODUCTS, LLC
5442
Not in Commercial Distribution

  • 01618125140137 ()


  • Urological fluid funnel, sterile

Vital Care - 01618125158095

Vital Care Urology Drain Bags Vinyl Sterile Fits Siemens Uroskop Access 20 per Case
TIDI PRODUCTS, LLC
29672
Not in Commercial Distribution

  • 01618125158095 ()


  • Urological fluid funnel, sterile

Accogent LLC - 01618125157357

Accogent LLC Urology Drain Bags Vinyl Sterile Fits Siemens Uroskop Access 20 per Case
TIDI PRODUCTS, LLC
29499
Not in Commercial Distribution

  • 00618125157358 ()
  • 01618125157357 ()


  • Non-wearable adult urine collection bag, open-ended

TIDIShield - 01618125142940

TIDIShield C-arm Equipment Covers Clear Polyethylene Sterile Fits Siemens Orbic C-Arm 10 per Case
TIDI PRODUCTS, LLC
31539
Not in Commercial Distribution

  • 00618125142941 ()
  • 01618125142940 ()


  • Medical equipment/instrument drape, single-use

JAC-CELL Medic - 01618125151973

JAC-CELL Medic Urology Drain Bags Vinyl Sterile Fits Siemens Uroskop Access 20 per Case
TIDI PRODUCTS, LLC
29529
Not in Commercial Distribution

  • 00618125151974 ()
  • 01618125151973 ()


  • Non-wearable adult urine collection bag, open-ended

Unimed - 06945664865920

ECG monitoring main cable/Siemens CT/SM type/ten lead/AHA/4.0M/LP16-3B/CSM
Unimed Medical Supplies, Inc.
TMCT-210880
In Commercial Distribution

  • 06945664865920 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664897686

ECG Monitoring Integrated Cable/Siemens CT/Three Leads/Button/AHA/2.5M+0.9M/LP4/pluscare
Unimed Medical Supplies, Inc.
P2363S
In Commercial Distribution

  • 06945664897686 ()


  • Electrocardiographic lead set, reusable

Unimed - 06945664886215

One piece ECG Monitor Cable/Siemens CT/3-lead/Snap/AHA/2.5M+0.9M/LP4/CSM
Unimed Medical Supplies, Inc.
C2363S0
In Commercial Distribution

  • 06945664886215 ()


  • Electrocardiographic lead set, reusable

Unimed - 06945664885423

One piece ECG Monitor Cable/Siemens CT/3-lead/Snap/AHA/2.5M+0.9M/LP4/Pacific
Unimed Medical Supplies, Inc.
NESM4131
In Commercial Distribution

  • 06945664885423 ()


  • Electrocardiographic lead set, reusable

INNOVANCE® D-Dimer - 00842768022821

For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Sysmex® Coagulation Systems
Siemens Healthcare Diagnostics Products GmbH
10445982
In Commercial Distribution

  • 00842768022821 ()
OPBP11

  • D-dimer IVD, kit, agglutination

INNOVANCE® D-Dimer - 00842768022814

For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Sysmex® Coagulation Systems
Siemens Healthcare Diagnostics Products GmbH
10445981
In Commercial Distribution

  • 00842768022814 ()
OPBP09

  • D-dimer IVD, kit, agglutination

N/T Protein Control PY - 00842768021138

Assayed control for Fibrinogen, Antithrombin III, Plasminogen and C1 Inhibitor assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446656
In Commercial Distribution

  • 00842768021138 ()
  • 00842768018565 ()
OWSY15

  • Plasma protein IVD, control

Apolipoprotein Control Serum CHD - 00842768021121

Assayed control for apolipoprotein A-I and B and CRP assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446469
In Commercial Distribution

  • 00842768021121 ()
  • 00842768018596 ()
OUPH09

  • Plasma protein IVD, control

N Protein Standard PY - 00842768021114

Calibration of Fibrinogen, Antithrombin III, Plasminogen and C1 Inhibitor assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446450
In Commercial Distribution

  • 00842768021114 ()
  • 00842768018732 ()
OUID15

  • Plasma protein IVD, calibrator

N Latex CDT Kit - 00842768018534

Quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445997
In Commercial Distribution

  • 00842768018534 ()
OPCS05

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

Multifibren® U - 00842768017872

Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10446691
In Commercial Distribution

  • 00842768017872 ()
  • 00842768018503 ()
OWZG23

  • Fibrinogen assay (factor I) IVD, reagent

Multifibren® U - 00842768017865

Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10446689
In Commercial Distribution

  • 00842768017865 ()
  • 00842768018541 ()
OWZG19

  • Fibrinogen assay (factor I) IVD, reagent

INNOVANCE Heparin - 00842768017438

For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)
Siemens Healthcare Diagnostics Products GmbH
10873535
In Commercial Distribution

  • 00842768017438 ()
OPOA05

  • Heparin anti-Xa IVD, kit, chromogenic

INNOVANCE Heparin LMW Control 1 - 00842768017100

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873534
In Commercial Distribution

  • 00842768017100 ()
  • 00630414229539 ()
OPOE05

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin LMW Control 2 - 00842768017094

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873533
In Commercial Distribution

  • 00842768017094 ()
  • 00630414229546 ()
OPOF05

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin UF Control 2 - 00842768017087

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873532
In Commercial Distribution

  • 00842768017087 ()
  • 00630414229522 ()
OPOD05

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin UF Control 1 - 00842768017070

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873531
In Commercial Distribution

  • 00842768017070 ()
  • 00630414229515 ()
OPOC05

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin Calibrator - 00842768017063

For calibration of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873530
In Commercial Distribution

  • 00842768017063 ()
OPOB05

  • Heparin anti-Xa IVD, calibrator

N/T Protein Control SL/M - 00842768016134

N/T Protein Control SL/M is a medium level, multi-analyte control for use as accuracy and precision control in the determination of human serum proteins by immunonephelometry with the BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446085
In Commercial Distribution

  • 00842768016134 ()
  • 00842768019036 ()
OQIO19

  • Plasma protein IVD, control

N/T Protein Control SL/L - 00842768016127

N/T Protein Control SL/L is a low level, multi-analyte control for use as accuracy and precision control in the determination of human serum proteins by immunonephelometry with the BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446079
In Commercial Distribution

  • 00842768016127 ()
  • 00842768019043 ()
OQIN19

  • Plasma protein IVD, control

N/T Protein Control SL/H - 00842768016110

N/T Protein Control SL/H is a high level, multi-analyte control for use as accuracy and precision control in the determination of human serum proteins by immunonephelometry with the BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446089
In Commercial Distribution

  • 00842768016110 ()
  • 00842768019029 ()
OQIP19

  • Plasma protein IVD, control

BCS® System Cuvette Rotors - 00842768014444

The BCS Cuvette Rotor is part of the BCS-XP system.
Siemens Healthcare Diagnostics Products GmbH
10446524
In Commercial Distribution

  • 00842768014444 ()
  • 00842768024603 ()
OVIP15

  • Coagulation analyser IVD, laboratory

Berichrom® Antithrombin III (A) - 00842768013478

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446673
In Commercial Distribution

  • 00842768013478 ()
OWWR17

  • Antithrombin III (ATIII) IVD, kit, chromogenic
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