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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Blood Oxygen Cable/Siemens/1.1M/007+170/Nellcor/Sage Services GROUP
Unimed Medical Supplies, Inc.
E09-11M
In Commercial Distribution

  • 06945664896054 ()


  • Electrical-only medical device connection cable, reusable
Reusable non-sterile solid couchtop panel for use with Siemens ZXT system
MEDTEC, INC.
MTIL300512
Not in Commercial Distribution

  • 00841439104491 ()

  • Width: 53 Inch
  • Length: 80 Centimeter
MTIL300512

  • Indexed-immobilization patient positioning system
High Sensitivity Troponin I (TnIH) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206269
In Commercial Distribution

  • 00630414293783 ()
11206269

  • Troponin I IVD, kit, chemiluminescent immunoassay
HCG Total (ThCG) - Atellica IM - RGT - 450T
Siemens Healthcare Diagnostics Inc.
11206261
In Commercial Distribution

  • 00630414294254 ()
  • 00630414293776 ()
11206261

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
T3 Total (T3) - Atellica IM - RGT 600T
Siemens Healthcare Diagnostics Inc.
11206260
In Commercial Distribution

  • 00630414294247 ()
  • 00630414293769 ()
11206260

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
Sex Hormone Binding Globulin (SHBG) - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
11206215
In Commercial Distribution

  • 00630414293752 ()
11206215

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
Intact Parathyroid Hormone (PTH) - Atellica IM - RGT 950T
Siemens Healthcare Diagnostics Inc.
11206268
In Commercial Distribution

  • 00630414293745 ()
11206268

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Prostate Specific Antigen (PSA) - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
11206259
In Commercial Distribution

  • 00630414294230 ()
  • 00630414293738 ()
11206259

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Prolactin (PRL) - Atellica IM - RGT 250
Siemens Healthcare Diagnostics Inc.
11206258
In Commercial Distribution

  • 00630414294223 ()
  • 00630414293721 ()
11206258

  • Prolactin IVD, kit, chemiluminescent immunoassay
Progesterone (PRGE) - Atellica IM - RGT 450T
Siemens Healthcare Diagnostics Inc.
11206257
In Commercial Distribution

  • 00630414294216 ()
  • 00630414293714 ()
11206257

  • Progesterone IVD, kit, chemiluminescent immunoassay
Luteinizing Hormone (LH) - Atellica IM - RGT - 550T
Siemens Healthcare Diagnostics Inc.
11206256
In Commercial Distribution

  • 00630414294209 ()
  • 00630414293707 ()
11206256

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Insulin (IRI) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11206267
In Commercial Distribution

  • 00630414293691 ()
11206267

  • Insulin IVD, kit, chemiluminescent immunoassay
Free T4 (FT4) - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206255
In Commercial Distribution

  • 00630414294193 ()
  • 00630414293684 ()
11206255

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Free T3 (FT3) - Atellica IM - RGT 300T
Siemens Healthcare Diagnostics Inc.
11206254
In Commercial Distribution

  • 00630414294186 ()
  • 00630414293677 ()
11206254

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Follicle Stimulating Hormone (FSH) - Atellica IM - RGT 950T
Siemens Healthcare Diagnostics Inc.
11206253
In Commercial Distribution

  • 00630414294179 ()
  • 00630414293660 ()
11206253

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Folic Acid (Fol) - Atellica IM - RGT 700T
Siemens Healthcare Diagnostics Inc.
11206252
In Commercial Distribution

  • 00630414293653 ()
11206252

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Ferritin (Fer) Atellica IM - RGT 450T
Siemens Healthcare Diagnostics Inc.
11206251
In Commercial Distribution

  • 00630414294162 ()
  • 00630414293646 ()
11206251

  • Ferritin IVD, kit, chemiluminescent immunoassay
Estradiol (eE2) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206250
In Commercial Distribution

  • 00630414293639 ()
11206250

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
DHEAS - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
11206197
In Commercial Distribution

  • 00630414293622 ()
11206197

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
C-Peptide (CpS) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11206249
In Commercial Distribution

  • 00630414293615 ()
11206249

  • C-peptide IVD, kit, chemiluminescent immunoassay
Cortisol - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206248
In Commercial Distribution

  • 00630414294155 ()
  • 00630414293608 ()
11206248

  • Total cortisol IVD, kit, chemiluminescent immunoassay
CKMB - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206247
In Commercial Distribution

  • 00630414294148 ()
  • 00630414293592 ()
11206247

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
CEA - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206246
In Commercial Distribution

  • 00630414294131 ()
  • 00630414293585 ()
11206246

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Calibrator E - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206245
In Commercial Distribution

  • 00630414294124 ()
  • 00630414293578 ()
11206245

  • Multiple steroid hormone IVD, calibrator
Calibrator D - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206244
In Commercial Distribution

  • 00630414294117 ()
  • 00630414293561 ()
11206244

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Calibrator C - Atellica IM - CAL (6PK) 6 x 2 x 5.0 mL
Siemens Healthcare Diagnostics Inc.
11206243
In Commercial Distribution

  • 00630414294100 ()
  • 00630414293554 ()
11206243

  • Multiple anaemia-related analyte IVD, calibrator
Calibrator B - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206242
In Commercial Distribution

  • 00630414294094 ()
  • 00630414293547 ()
11206242

  • Multiple human hormone IVD, calibrator
Calibrator A - Atellica IM - CAL (6PK) 2 x 6 x 5.0 mL
Siemens Healthcare Diagnostics Inc.
11206241
In Commercial Distribution

  • 00630414294087 ()
  • 00630414293530 ()
11206241

  • Multiple human hormone IVD, calibrator
Calibrator 30 - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206240
In Commercial Distribution

  • 00630414294070 ()
  • 00630414293523 ()
11206240

  • Multiple steroid hormone IVD, calibrator
CA 19-9 Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206239
In Commercial Distribution

  • 00630414293516 ()
11206239

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
CA 15-3 Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206238
In Commercial Distribution

  • 00630414294063 ()
  • 00630414293509 ()
11206238

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
CA 125II Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206266
In Commercial Distribution

  • 00630414294278 ()
  • 00630414293493 ()
11206266

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
BR Calibrator - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206237
In Commercial Distribution

  • 00630414294056 ()
  • 00630414293486 ()
11206237

  • Cancer antigen 27-29 (CA27-29) IVD, calibrator
BR CA27-29 - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206236
In Commercial Distribution

  • 00630414294049 ()
  • 00630414293479 ()
11206236

  • Cancer antigen 27-29 (CA27-29) IVD, kit, chemiluminescent immunoassay
BNP - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206235
In Commercial Distribution

  • 00630414294032 ()
  • 00630414293462 ()
11206235

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
Dimenison Vista Lipase Flex reagent cartridge
Siemens Healthcare Diagnostics Inc.
11538128
In Commercial Distribution

  • 00630414306254 ()
  • 00630414292762 ()
K3056A

  • Lipase IVD, kit, spectrophotometry
Dimension/Vista Lipase Calibrator
Siemens Healthcare Diagnostics Inc.
11538127
In Commercial Distribution

  • 00630414292755 ()
DC56B

  • Lipase IVD, calibrator
Dimension Lipase (LIP) Flex reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
11538126
In Commercial Distribution

  • 00630414306247 ()
  • 00630414292748 ()
DF56A

  • Lipase IVD, kit, spectrophotometry
Lithium_2 (LITH_2) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11532401
In Commercial Distribution

  • 00630414287935 ()
11532401

  • Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy
Lactate_2 (Lac_2) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11532568
Not in Commercial Distribution

  • 00630414287270 ()
11532568

  • Lactate IVD, kit, spectrophotometry
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