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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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BUSULFAN 100 NG/ML - B800BUS100VPFCHLA0

BUSULFAN 100 NG/ML
UTAK LABORATORIES, INC.
BUS 100 V P F CHLA
In Commercial Distribution

  • B800BUS100VPFCHLA5 ()
  • B800BUS100VPFCHLA0 ()
  • B800BUS100VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 100 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control

BUSULFAN 1000 NG/ML - B800BUS1000VPFCHLA0

BUSULFAN 1000 NG/ML
UTAK LABORATORIES, INC.
BUS 1000 V P F CHLA
In Commercial Distribution

  • B800BUS1000VPFCHLA5 ()
  • B800BUS1000VPFCHLA0 ()
  • B800BUS1000VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 1000 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control

ACETONE BLANK - B800ACEBLKSFBSRHS0

ACETONE BLANK
UTAK LABORATORIES, INC.
ACE BLK S F BSRHS
In Commercial Distribution

  • B800ACEBLKSFBSRHS5 ()
  • B800ACEBLKSFBSRHS0 ()
  • B800ACEBLKSFBSRHS55 ()

  • Total Volume: 1 Milliliter
ACE BLK S F BSRHS

  • Multiple-type clinical chemistry analyte profile IVD, control

Soviflex - B79510010

Post-parturition vaginal retractor intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g. suturing) of vaginal tears.
Birch Concepts LLC
1001
In Commercial Distribution

  • B79510011 ()
  • B79510010 ()
  • B79510012 ()
1001

  • Post-parturition vaginal retractor

SPEAX Patch - B792FGN002

Patch for use with the SPEAX Communication System
ATAIA INC.
FGN-002
In Commercial Distribution

  • B792FGN003 ()
  • B792FGN002 ()
  • B792FGN012 ()
FGN002

  • Voice amplification system

OLO CBC Test Kit - B787TK10

A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
S.D. SIGHT DIAGNOSTICS LTD
TK1
In Commercial Distribution

  • B787TK10 ()
  • B787TK11 ()
  • B787TK12 ()


  • Full blood count IVD, kit, cell count

DRUGS OF ABUSE LEVEL 3 - B800DAU3V2FUVMG0

DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DAU 3 V2 F U VMG
In Commercial Distribution

  • B800DAU3V2FUVMG0 ()
  • B800DAU3V2FUVMG05 ()
  • B800DAU3V2FUVMG5 ()

  • Total Volume: 10 Milliliter
DAU 3 V2 F U VMG

  • Multiple drugs of abuse IVD, control

10mm Gas Sample Adaptor - B882900060

90006 is a kit containing two off-the-shelf components. - 1: (61922) 10M-10F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 10mm-diameter breathing circuit.
Beyond Air, Inc.
90006
In Commercial Distribution

  • B882900061 ()
  • B882900060 ()
  • B882900062 ()


  • Nitric oxide delivery system, secondary

LungFit PH Bagging Kit - B882900050

The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main delivery system; it has its own NO generator and gas flow delivery system. Backup NO flow can be delivered to one of two different locations by using the System Selector switch located on the front panel of the LungFit PH system. When the Selector Switch is turned to “Bagging System” position, the backup NO module turns on and delivers 1 L/min of 220 ppm of NO through a separate internal NO2 filter to the Bagging System connector on the front panel of the LungFit PH system. The Bagging System connector has two tubing fittings: one for connecting to an air/oxygen source through oxygen tubing or equivalent to provide an external flow of air/oxygen and the other to connect to a manual resuscitator for manually ventilating a patient. The 1 L/min NO flow from the backup NO module is added to this air/oxygen flow which dilutes the NO concentration down to therapeutic levels. Final NO concentration will depend on the amount of external flow added; for example, a flow of 10 L/min will provide 20 ppm of NO to the patient.
Beyond Air, Inc.
90005
In Commercial Distribution

  • B882900051 ()
  • B882900050 ()
  • B882900052 ()


  • Nitric oxide delivery system, secondary

XCELL - B708XCPSPC1200

XCELL PC Fluid Volume Reducer 120ml XC-PSPC-120
APEX BIOLOGIX , LLC
XC-PSPC-120
In Commercial Distribution

  • B708XCPSPC1201 ()
  • B708XCPSPC1200 ()
  • B708XCPSPC1202 ()


  • Haematological concentrate system preparation kit, platelet concentration

Lucitone® HIPA - D0019059540

Original Opaque
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059561 ()
  • D0019059540 ()
  • D0019060222 ()

  • Weight: 1000 Gram
905954

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059320

Original
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059421 ()
  • D0019059320 ()
  • D0019060182 ()

  • Weight: 1000 Gram
905932

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059350

Dark Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019060212 ()
  • D0019059451 ()
  • D0019059350 ()

  • Weight: 1000 Gram
905935

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059340

Light Reddish Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059441 ()
  • D0019059340 ()
  • D0019060202 ()

  • Weight: 1000 Gram
905934

  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059330

Light
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019060192 ()
  • D0019059431 ()
  • D0019059330 ()

  • Weight: 1000 Gram
905933

  • Dental appliance fabrication material, resin

Quala - D023GCPKA1

Quala Mask Surgical Molded Pink
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCPKA
In Commercial Distribution

  • D023GCPKA5 ()
  • D023GCPKA3 ()
  • D023GCPKA1 ()
GCPKA

  • Surgical/medical respirator, non-antimicrobial, single-use

Quala - D023GCIPKA1

Quala Mask Earloop Latex Free Pink
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCIPKA
In Commercial Distribution

  • D023GCIPKA5 ()
  • D023GCIPKA3 ()
  • D023GCIPKA1 ()
GCIPKA

  • Surgical/medical respirator, non-antimicrobial, single-use

Quala - D023GCILVA1

Quala Mask Earloop Latex Free Lavender
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCILVA
In Commercial Distribution

  • D023GCILVA50 ()
  • D023GCILVA3 ()
  • D023GCILVA1 ()
GCILVA

  • Surgical/medical respirator, non-antimicrobial, single-use

Quala - D023GCIBLA1

Quala Mask Earloop Latex Free Blue
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCIBLA
In Commercial Distribution

  • D023GCIBLA5 ()
  • D023GCIBLA3 ()
  • D023GCIBLA1 ()
GCIBLA

  • Surgical/medical respirator, non-antimicrobial, single-use

Quala - D023GCBLA13

Quala Mask Surgical Molded Blue
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCBLA
In Commercial Distribution

  • D023GCBLA55 ()
  • D023GCBLA33 ()
  • D023GCBLA13 ()
GCBLA

  • Surgical/medical respirator, non-antimicrobial, single-use

COE® - D6582600511

COE® Regular-Perforated, Individual Tray, #5 Upper
Gc America Inc.
260051
In Commercial Distribution

  • D6582600514 ()
  • D6582600512 ()
  • D6582600511 ()
260051

  • Dental impression tray, reusable

COE® - D6582600411

COE® Regular-Perforated, Individual Tray, #4 Upper
Gc America Inc.
260041
In Commercial Distribution

  • D6582600414 ()
  • D6582600412 ()
  • D6582600411 ()
260041

  • Dental impression tray, reusable

COE® - D6582600311

COE® Regular Perforated Individual Tray, #3 Upper
Gc America Inc.
260031
In Commercial Distribution

  • D6582600312 ()
  • D6582600311 ()
  • D6582600314 ()
260031

  • Dental impression tray, reusable

COE® - D6582600111

COE® Regular-Perforated Individual tray, #1 Upper XL
Gc America Inc.
260011
In Commercial Distribution

  • D6582600112 ()
  • D6582600111 ()
  • D6582600114 ()
260011

  • Dental impression tray, reusable

COE® - D6582503211

COE® SPACER TRAYS #32D Anterior Perforated-Partial
Gc America Inc.
250321
In Commercial Distribution

  • D6582503262 ()
  • D6582503211 ()
  • D6582532124 ()
  • D6582503210 ()
250321

  • Dental impression tray, single-use

COE® - D6582503111

COE® SPACER TRAYS #31D Upper R, Lower L Perforated-Partial
Gc America Inc.
250311
In Commercial Distribution

  • D6582503162 ()
  • D6582503111 ()
  • D6582531124 ()
  • D6582503110 ()
250311

  • Dental impression tray, single-use

COE® - D6582503011

COE® SPACER TRAYS #30D Upper L, Lower R Perforated-Partial
Gc America Inc.
250301
In Commercial Distribution

  • D6582503062 ()
  • D6582503011 ()
  • D6582530124 ()
  • D6582503010 ()
250301

  • Dental impression tray, single-use

COE® - D6582502211

COE® SPACER TRAYS #22D Small Lower Perforated
Gc America Inc.
250221
In Commercial Distribution

  • D6582502262 ()
  • D6582502211 ()
  • D6582522124 ()
  • D6582502210 ()
250221

  • Dental impression tray, single-use

COE® - D6582502111

COE® SPACER TRAYS #21D Medium Lower Perforated
Gc America Inc.
250211
In Commercial Distribution

  • D6582502162 ()
  • D6582502111 ()
  • D6582521124 ()
  • D6582502110 ()
250211

  • Dental impression tray, single-use

COE® - D6582502011

COE® SPACER TRAYS #20D Large Lower Perforated
Gc America Inc.
250201
In Commercial Distribution

  • D6582520124 ()
  • D6582502062 ()
  • D6582502011 ()
  • D6582502010 ()
250201

  • Dental impression tray, single-use

COE® - D6582500961

COE® SPACER TRAYS Perforated Assorted Package
Gc America Inc.
250096
In Commercial Distribution

  • D6582500962 ()
  • D6582500961 ()
  • D6582501124 ()
  • D6582500960 ()
250096

  • Dental impression tray, single-use

COE® - D6582500711

COE® SPACER TRAYS #7D Small Upper Perforated
Gc America Inc.
250071
In Commercial Distribution

  • D6582500762 ()
  • D6582500711 ()
  • D6582507124 ()
  • D6582500710 ()
250071

  • Dental impression tray, single-use

COE® - D6582500411

COE® SPACER TRAYS #4D Medium Upper Perforated
Gc America Inc.
250041
In Commercial Distribution

  • D6582500462 ()
  • D6582500411 ()
  • D6582504124 ()
  • D6582500410 ()
250041

  • Dental impression tray, single-use

COE® - D6582500111

COE® SPACER TRAYS #1D Large Upper Perforated
Gc America Inc.
250011
In Commercial Distribution

  • D6582500124 ()
  • D6582500162 ()
  • D6582500111 ()
  • D6582500110 ()
250011

  • Dental impression tray, single-use

COE® - D6582672011

COE® Check-Bite™ #72, Unilateral, Non-Water Cooled
Gc America Inc.
267201
In Commercial Distribution

  • D6582672012 ()
  • D6582672011 ()
  • D6582672014 ()
  • D6582672010 ()
267201

  • Dental impression tray, reusable

COE® - D6582670011

COE® Check-Bite™ #70, Unilateral, Water Cooled, for Hydrocolloid
Gc America Inc.
267001
In Commercial Distribution

  • D6582670012 ()
  • D6582670011 ()
  • D6582670014 ()
  • D6582670010 ()
267001

  • Dental impression tray, reusable

COE® - D6582643311

COE® Stainless Steel-Perforated Partials Individual Tray #S33 Anterior Upper
Gc America Inc.
264331
In Commercial Distribution

  • D6582643314 ()
  • D6582643312 ()
  • D6582643311 ()
264331

  • Dental impression tray, reusable

COE® - D6582643211

COE® Stainless Steel-Perforated Partials Individual Trays #S32 Anterior Lower
Gc America Inc.
264321
In Commercial Distribution

  • D6582643212 ()
  • D6582643211 ()
  • D6582643214 ()
264321

  • Dental impression tray, reusable

COE® - D6582643111

COE® Stainless Steel-Perforated Partials Individual Trays #S31 Left Unilateral
Gc America Inc.
264311
In Commercial Distribution

  • D6582643112 ()
  • D6582643111 ()
  • D6582643114 ()
264311

  • Dental impression tray, reusable

COE® - D6582643011

COE® Stainless Steel-Perforated Partials Individual Trays #S30 Right Unilateral
Gc America Inc.
264301
In Commercial Distribution

  • D6582643014 ()
  • D6582643012 ()
  • D6582643011 ()
264301

  • Dental impression tray, reusable
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