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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No Description
MAR COR PURIFICATION, INC.
BICARB SYSTEM,MCB212-100,LG DIST PUMP
In Commercial Distribution

  • 00817492021310 ()

  • Width: 85 Inch
  • Depth: 32 Inch
  • Height: 61 Inch
  • Weight: 350 Pound


  • Haemodialysis bicarbonate solution preparation mixer
The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood, heparinized plasma, or serum. This kit contains additional accessories for supporting US military requirements. The Piccolo Xpress is a portable clinical chemistry system designed for accurate, on-site patient testing. It allows healthcare practitioners to perform routine multi-chemistry panels using 0.1cc of whole blood, serum or plasma. The system uses patented single-use reagent discs which contain up to 14 chemistry tests. Simply pipette the sample into the disc, insert the disc into the analyzer and results are printed or transferred to an LIS/EMR in about 12 minutes. No operator intervention is required. The Piccolo Xpress employs on-board continuous intelligent Quality Control (iQC®) to monitor the analyzer, reagent reactions and sample to ensure the highest quality and accuracy in results.
ABAXIS, INC.
1100-1511
In Commercial Distribution

  • EABA11001511 ()

  • Height: 32.5 Centimeter
  • Width: 14.9 Centimeter
  • Depth: 21.0 Centimeter
  • Weight: 5.3 Kilogram
1100-1511

  • Centrifugal clinical chemistry analyser
The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood, heparinized plasma, or serum. The Piccolo Xpress is a portable clinical chemistry system designed for accurate, on-site patient testing. It allows healthcare practitioners to perform routine multi-chemistry panels using 0.1cc of whole blood, serum or plasma. The system uses patented single-use reagent discs which contain up to 14 chemistry tests. Simply pipette the sample into the disc, insert the disc into the analyzer and results are printed or transferred to an LIS/EMR in about 12 minutes. No operator intervention is required. The Piccolo Xpress employs on-board continuous intelligent Quality Control (iQC®) to monitor the analyzer, reagent reactions and sample to ensure the highest quality and accuracy in results.
ABAXIS, INC.
1100-0000
In Commercial Distribution

  • EABA110000001 ()

  • Weight: 5.3 Kilogram
  • Depth: 21.0 Centimeter
  • Width: 14.9 Centimeter
  • Height: 32.5 Centimeter
1100-0000

  • Centrifugal clinical chemistry analyser
1.25cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN012
In Commercial Distribution

  • 00865179000073 ()
IQSP-PP-101

  • Synthetic bone graft
2.5cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN010
In Commercial Distribution

  • 00865179000066 ()
IQSP-PP-102

  • Synthetic bone graft
5cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN009
In Commercial Distribution

  • 00865179000059 ()
IQSP-PP-105

  • Synthetic bone graft
10cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN008
In Commercial Distribution

  • 00865179000042 ()
IQSP-PP-110

  • Synthetic bone graft
Ginevra Purple Mix Spectacle
Kenmark Optical, Inc.
GINEPU54
In Commercial Distribution

  • 00715317064644 ()


  • Tinted non-prescription spectacles
Ginevra Grey Mix Spectacle
Kenmark Optical, Inc.
GINEGR54
In Commercial Distribution

  • 00715317064637 ()


  • Tinted non-prescription spectacles
V359 Green Mix Spectacle
Kenmark Optical, Inc.
V359GN53
In Commercial Distribution

  • 00715317028035 ()


  • Prescription spectacles
V359 Green Mix Spectacle
Kenmark Optical, Inc.
V359GN51
In Commercial Distribution

  • 00715317028028 ()


  • Prescription spectacles
HEALQU Elastic Bandage Mix
Healqu LLC
902532535-45
In Commercial Distribution

  • 00819143023797 ()
  • 00819143023278 ()


  • Pressure bandage, non-latex, single-use
MIX TIP GREEN 50PK
DEN-MAT HOLDINGS, LLC
SPD1181
In Commercial Distribution

  • D813SPD11810 ()
  • D813SPD11811 ()
SPD1181

  • Silicone dental impression material
MIX TIP PURPLE 50PK
DEN-MAT HOLDINGS, LLC
SPD1180
In Commercial Distribution

  • D813SPD11800 ()
  • D813SPD11801 ()
SPD1180

  • Silicone dental impression material
H&V MIX SV
DIAGNOSTIC HYBRIDS, INC.
98-0101
In Commercial Distribution

  • 30014613335252 ()
98-0101

  • Cell culture line IVD
Visalys Veneer Composite Mix
Kettenbach GmbH & Co. KG
28456
Not in Commercial Distribution

  • E217284561 ()
28456

  • Dental composite resin
SHOWER & DISINFECTION PANEL, WHITE, US, with FLUSH VALVE
Arjohuntleigh AB
BCA1224-04
In Commercial Distribution

  • 05055982707954 ()
BCA1224-04

  • Shower unit
SHOWER & DISINFECTION PANEL, WHITE, US, with FLUSH TANK
Arjohuntleigh AB
BCA1214-04
In Commercial Distribution

  • 05055982707916 ()
BCA1214-04

  • Shower unit
SHOWER & DISINFECTION PANEL, WHITE, US
Arjohuntleigh AB
BCA1204-04
In Commercial Distribution

  • 05055982707879 ()
BCA1204-04

  • Shower unit
MULTICLEAN with Arjo Spray handle
Arjohuntleigh AB
BPA1101-US
In Commercial Distribution

  • 05055982706445 ()
BPA1101-US

  • Shower unit
MULTICLEAN with Oras Spray handle
Arjohuntleigh AB
BPA1100-US
In Commercial Distribution

  • 05055982706438 ()
BPA1100-US

  • Shower unit
SHOWERING AND BATHING HYGIENE ASSIST
M.A.S. MEDICAL SRL
WIB
In Commercial Distribution

  • 08054117850166 ()
200000

  • Shower unit
CEKA Multi COMPOSITE O
Alphadent NV
6711B
In Commercial Distribution

  • 04260576941541 ()

  • Weight: 8 Gram
  • dual mix composite cement
6711B

  • Dentine bonding agent/set
CEKA Multi COMPOSITE
Alphadent NV
6701B
In Commercial Distribution

  • 04260576941510 ()

  • Weight: 8 Gram
  • dual mix composite cement
6701B

  • Dentine bonding agent/set
CEKA Multi SET
Alphadent NV
6700B
In Commercial Distribution

  • 04260576941503 ()

  • dual mix composite cement
  • Weight: 8 Gram
6700B

  • Dentine bonding agent/set
TRACOE cleaning brushes for flexible tracheostomy tubes set
Tracoe medical GmbH
REF 941
Not in Commercial Distribution

  • 04035324012268 ()

  • mix of different sizes


  • Airway device cleaning utensil, noninvasive, reusable
TRACOE cleaning brushes with wool tip set
Tracoe medical GmbH
REF 939
Not in Commercial Distribution

  • 04035324012206 ()

  • mix of different sizes


  • Airway device cleaning utensil, noninvasive, reusable
No Description
Coltène/Whaledent AG
4392
Not in Commercial Distribution

  • J00643920 ()
4392

  • Silicone dental impression material
Analytes Mix, VMA, HVA, 5-HIAA in urine
Chromsystems Instruments + Chemicals GmbH
1033
In Commercial Distribution

  • 04250317557605 ()
  • 04250317557612 ()

  • Total Volume: 5 Milliliter
1033

  • HVA/VMA/5HIAA IVD, reagent
No Description
Endo Direct LLC
EDRCMIX
In Commercial Distribution

  • 10810138823276 ()


  • Root canal cleaning solution
LABEL SHEET CSTM GOLDENER MIX
MEDLINE INDUSTRIES, INC.
LBL1015942GD
In Commercial Distribution

  • 40889942873686 ()
  • 10889942873685 ()
LBL1015942GD

  • General surgical procedure kit, non-medicated, single-use
CEKA MIX TIPS 20 PCS.
Alphadent NV
6705B
In Commercial Distribution

  • 04260576941534 ()
  • 14260576941531 ()
6705

  • Dental material injection cannula, single-use
Direct To Consumer Mix Packs
Cora
Various
In Commercial Distribution

  • 00850373007904 ()
  • 00850373007041 ()


  • Menstrual tampon, unscented
CompCore AF SYRINGE MIX STACK-BLUE
PREMIER DENTAL PRODUCTS COMPANY
3001514
In Commercial Distribution

  • 00348783000788 ()


  • Dental composite resin
CompCore AF SYRINGE MIX STACK-WHITE
PREMIER DENTAL PRODUCTS COMPANY
3001512
In Commercial Distribution

  • 00348783000764 ()


  • Dental composite resin
MIX TIPS & INTRAORAL TIPS (35)
PREMIER DENTAL PRODUCTS COMPANY
3001417
In Commercial Distribution

  • 00348783003727 ()


  • Dental material mixing nozzle
Miracle Mix® Capsules (48)
Gc America Inc.
452100
In Commercial Distribution

  • D6584521001 ()
  • D6584521000 ()
452100

  • Glass ionomer dental cement
EVI1 Mix in Aqua Spectrum
CYTOCELL LIMITED
MPH10033
In Commercial Distribution

  • 05055844910393 ()


  • Assay development analyte-specific reagent IVD
Interference Mix, Metanephrines in urine
Chromsystems Instruments + Chemicals GmbH
2099
In Commercial Distribution

  • 04250317503299 ()

  • 10 ml
2099

  • Multiple biogenic amine neurotransmitter IVD, reagent
VP Mix 380 Standard Pack
HENRY SCHEIN, INC.
9004597
In Commercial Distribution

  • 10304040003869 ()
  • 00304040003862 ()
9004597

  • Silicone dental impression material
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