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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Syva® Emit® Calibrator/Control Level 1
Siemens Healthcare Diagnostics Inc.
10445407
In Commercial Distribution

  • 00842768001741 ()
9A529UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® Calibrator/Control Level 0 (negative)
Siemens Healthcare Diagnostics Inc.
10445406
In Commercial Distribution

  • 00842768001734 ()
9A509UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® Calibrator Level 0 (negative)
Siemens Healthcare Diagnostics Inc.
10445403
In Commercial Distribution

  • 00842768001703 ()
9A049UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® 2000 Tacrolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445399
In Commercial Distribution

  • 00842768001680 ()
8R109UL

  • Tacrolimus therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Tacrolimus Assay
Siemens Healthcare Diagnostics Inc.
10445397
In Commercial Distribution

  • 00842768001666 ()
8R019UL

  • Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® tox Salicylic Acid Calibrators
Siemens Healthcare Diagnostics Inc.
10445393
In Commercial Distribution

  • 00842768001628 ()
7S109UL

  • Salicylate IVD, calibrator
Syva® Emit® tox Salicylic Acid Assay
Siemens Healthcare Diagnostics Inc.
10445392
In Commercial Distribution

  • 00842768001611 ()
7S019UL

  • Salicylate IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® tox Serum Barbiturate Assay
Siemens Healthcare Diagnostics Inc.
10445391
In Commercial Distribution

  • 00842768001604 ()
7D119UL

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® tox Serum Benzodiazepine Assay
Siemens Healthcare Diagnostics Inc.
10445388
In Commercial Distribution

  • 00842768001581 ()
7B119UL

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® tox Serum Calibrators
Siemens Healthcare Diagnostics Inc.
10445387
In Commercial Distribution

  • 00842768001574 ()
7B019UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® tox Acetaminophen Calibrators
Siemens Healthcare Diagnostics Inc.
10445386
In Commercial Distribution

  • 00842768001567 ()
7A409UL

  • Acetaminophen IVD, calibrator
Syva® Emit® tox Acetaminophen Assay
Siemens Healthcare Diagnostics Inc.
10445385
In Commercial Distribution

  • 00842768001550 ()
7A319UL

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Amikacin Assay
Siemens Healthcare Diagnostics Inc.
10445383
In Commercial Distribution

  • 00842768001543 ()
6X019UL

  • Amikacin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Cyclosporine Sample Pretreatment Reagent
Siemens Healthcare Diagnostics Inc.
10445378
In Commercial Distribution

  • 00842768001482 ()
  • 00630414010533 ()
6R719UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
Emit ® 2000 Cyclosporine Specific Negative Calibrator
Siemens Healthcare Diagnostics Inc.
10445377
In Commercial Distribution

  • 00842768001475 ()
  • 00630414024523 ()
6R319UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Emit® 2000 Cyclosporine Specific Calibrators, 6 levels
Siemens Healthcare Diagnostics Inc.
10445376
In Commercial Distribution

  • 00842768001468 ()
6R119UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Emit ® 2000 Cyclosporine Specific Assay
Siemens Healthcare Diagnostics Inc.
10445375
In Commercial Distribution

  • 00842768001451 ()
6R079UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Caffeine Control
Siemens Healthcare Diagnostics Inc.
10445372
In Commercial Distribution

  • 00842768001420 ()
6P499UL

  • Caffeine IVD, control
Syva® Emit® Caffeine Assay
Siemens Healthcare Diagnostics Inc.
10445371
In Commercial Distribution

  • 00842768001413 ()
6P419UL

  • Caffeine IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Disopyramide Assay
Siemens Healthcare Diagnostics Inc.
10445370
In Commercial Distribution

  • 00842768001406 ()
6N319UL

  • Disopyramide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Lidocaine Assay
Siemens Healthcare Diagnostics Inc.
10445369
In Commercial Distribution

  • 00842768001390 ()
6M119UL

  • Lidocaine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Methotrexate Assay
Siemens Healthcare Diagnostics Inc.
10445368
In Commercial Distribution

  • 00842768001383 ()
6L119UL

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Primidone Assay
Siemens Healthcare Diagnostics Inc.
10445366
In Commercial Distribution

  • 00842768001376 ()
6C119UL

  • Primidone therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® RapidTest d.a.u.® BZO, Benzodiazepines
Siemens Healthcare Diagnostics Inc.
10445365
In Commercial Distribution

  • 00842768001369 ()
  • 00630414027401 ()
6A449UL

  • Benzodiazepine group IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 4 THC / OPI / COC/ mAMP
Siemens Healthcare Diagnostics Inc.
10445364
In Commercial Distribution

  • 00842768001352 ()
  • 00630414013985 ()
6A339UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A-LYTE™ IMT (Na K Cl) Atellica CH - RGT
Siemens Healthcare Diagnostics Inc.
11099315
In Commercial Distribution

  • 00630414596518 ()
  • 00630414006833 ()
11099315

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Small reference chamber holder for attachment to a Siemens Oncor Linac head
IBA Dosimetry GmbH
MC000000
In Commercial Distribution

  • EIBAMC0000000 ()


  • Radiation electrometer
One-piece ECG Monitor Cable Siemens 5-lead shielded snap end 10pins plug/AHA
Unimed Medical Supplies, Inc.
P2576S
In Commercial Distribution

  • 06936735463411 ()


  • Electrocardiographic lead set, reusable
One-piece ECG Monitor Cable Siemens 5-lead shielded grabber end 10pins plug/AHA
Unimed Medical Supplies, Inc.
P2576P
In Commercial Distribution

  • 06936735463404 ()


  • Electrocardiographic lead set, reusable
One-piece ECG Monitor Cable Siemens 3-lead shielded snap end 7pins plug/AHA
Unimed Medical Supplies, Inc.
P2323S
In Commercial Distribution

  • 06936735462971 ()


  • Electrocardiographic lead set, reusable
One-piece ECG Monitor Cable Siemens 3-lead shielded grabber end 7pins plug/AHA
Unimed Medical Supplies, Inc.
P2323P
In Commercial Distribution

  • 06936735462964 ()


  • Electrocardiographic lead set, reusable
ECG Monitor Lead Wire Siemens Style 3-lead shielded grabber end 0.9m/AHA
Unimed Medical Supplies, Inc.
SMD3-90P
In Commercial Distribution

  • 06936735460908 ()


  • Electrocardiographic lead set, reusable
One-piece ECG Monitor Cable Siemens 3-lead shielded snap end 10pins plug/AHA
Unimed Medical Supplies, Inc.
P2376S
In Commercial Distribution

  • 06936735462674 ()


  • Electrocardiographic lead set, reusable
One-piece ECG Monitor Cable Siemens 3-lead shielded grabber end 10pins plug/AHA
Unimed Medical Supplies, Inc.
P2376P
In Commercial Distribution

  • 06936735462667 ()


  • Electrocardiographic lead set, reusable
3-adriges Komplettkabel, zu Siemens ACUSON X300 Juniper, mit Klammern,340 cm lang
Unimed Medical Supplies, Inc.
2-3-S16
In Commercial Distribution

  • 06936735490387 ()


  • Electrocardiographic lead set, reusable
CATHETER SOUNDSTAR 3D DIAGNOSTIC ULTRASOUND FOR USE ON SIEMENS IMAGING SYSTEM 10FR
STERILMED, INC.
BIOSNDSTR10
In Commercial Distribution

  • 10888551007115 ()
BIOSNDSTR10

  • Intracardiac ultrasound imaging catheter, steerable, reprocessed
SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON SIEMENS IMAGING SYSTEM
STERILMED, INC.
R10439011
In Commercial Distribution

  • 10888551045087 ()
R10439011

  • Intracardiac ultrasound imaging catheter, steerable, reprocessed
ClearPoint Inflexion Avanto HFF (for Siemens Avanto/Espree/Symphony/Sonata/Verio/Trio)
Clearpoint Neuro, Inc.
CP-INHFF-112-01
In Commercial Distribution

  • 00850376007482 ()
CP-INHFF-112-01

  • Skull clamp
Siemens 19" display spacer, to make rear of monitor flush for mounting
SKYTRON LLC
SIEMENS-ADAPTER
In Commercial Distribution

  • 10841736114879 ()


  • General utility supply system, ceiling-mounted
Siemens labelling, including locking collets (pack of 25) and needle collet wrench
Varian Medical Systems Deutschland GmbH
GM11012260
In Commercial Distribution

  • 00816389020276 ()
GM11012260

  • General-purpose brachytherapy system applicator, remote-afterloading
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