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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CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600284-001
In Commercial Distribution

  • J00716002840011 ()
1600284-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600200-001
In Commercial Distribution

  • J00716002000011 ()
1600200-001

  • Dental power tool system handpiece, remotely-driven
No Description
Thoratec Corporation
107754OUS
Not in Commercial Distribution

  • 00813024013006 ()
107754OUS

  • Basic power supply, reusable
No Description
Roche Diagnostics GmbH
5917972160
In Commercial Distribution

  • 04015630927906 ()
5917972160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
11776240322
In Commercial Distribution

  • 04015630918409 ()
11776240322

  • Cancer antigen 125 (CA125) IVD, calibrator
No Description
Roche Diagnostics GmbH
3045846122
In Commercial Distribution

  • 04015630918225 ()
3045846122

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
No Description
Roche Diagnostics GmbH
7762011190
In Commercial Distribution

  • 04015630946303 ()
7762011190

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
11776223161
In Commercial Distribution

  • 04015630945795 ()
11776223161

  • Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
3045838160
In Commercial Distribution

  • 04015630934379 ()
3045838160

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)
For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873440
In Commercial Distribution

  • 00842768039416 ()
  • 00842768019845 ()
B4265-37

  • Buffered sample diluent IVD
No Description
Drägerwerk AG & Co. KGaA
8418584
Not in Commercial Distribution

  • 04048675028000 ()


  • Nasal oxygen cannula, CPAP
Interface Cable to interface Transducer to Monitor. It has a 6-pin monitor connector and the cable length is 150"
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684085
In Commercial Distribution

  • 50886333640855 ()
  • 00886333640850 ()

  • cable length 150"
684085

  • Electrical-only medical device connection cable, reusable
Interface Cable to interface Transducer to Monitor. It has a 8-pin monitor connector and the cable length is 150"
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684082
In Commercial Distribution

  • 50886333640824 ()
  • 00886333640829 ()

  • cable length 150"
684082

  • Electrical-only medical device connection cable, reusable
Interface Cable to interface Transducer to Monitor. It has a 6-pin monitor connector and the cable length is 150"
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684078
In Commercial Distribution

  • 50886333640787 ()
  • 00886333640782 ()

  • cable length 150"
684078

  • Electrical-only medical device connection cable, reusable
Interface cable of 150" cable length with a round shape, 5-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684241
In Commercial Distribution

  • 50886333642415 ()
  • 00886333642410 ()

  • Cable length 150"
684241

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 12-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684230
In Commercial Distribution

  • 50886333642309 ()
  • 00886333642304 ()

  • cable length 150"
684230

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 4-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684188
In Commercial Distribution

  • 50886333641883 ()
  • 00886333641888 ()

  • cable length 150"
684188

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 8-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684183
In Commercial Distribution

  • 50886333641838 ()
  • 00886333641833 ()

  • cable length 150"
684183

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 5-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684147
In Commercial Distribution

  • 50886333641470 ()
  • 00886333641475 ()

  • cable length 150"
684147

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 6-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684139
In Commercial Distribution

  • 50886333641395 ()
  • 00886333641390 ()

  • cable length 150"
684139

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 5-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684138
In Commercial Distribution

  • 50886333641388 ()
  • 00886333641383 ()

  • cable length 150"
684138

  • Electrical-only medical device connection cable, reusable
AS-895 Columbia Blood Agar (CA) is intended for the isolation, quantitation, and partial identification of a variety of microorganisms, including fastidious organisms from clinical specimens. CA is suitable for use in antibiotic differential disk examination and spot biochemical testing. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque red. 4 plates per pack.
ANAEROBE SYSTEMS
AS-895
In Commercial Distribution

  • 00810048902354 ()
  • 00810048901166 ()
AS-895

  • Enriched agar culture medium IVD
Contains DIs: E235253A0; E235256A0; E235259A0; E235251A0; E235254A0; E235257A0;E23502530; E23502560; E23502230; E23502280
SHOFU DENTAL CORPORATION
0317B
In Commercial Distribution

  • E2350317B0 ()
0317B

  • Dental abrasive point, reusable
Contains DIs: E23504030; E23504040; E23504010; E23504020; E23502820; E23502850; E23502830; E23502860
SHOFU DENTAL CORPORATION
0308B
In Commercial Distribution

  • E2350308B0 ()
0308B

  • Dental abrasive point, reusable
No Description
Epocal Inc
HH-1R09-CA-00
In Commercial Distribution

  • 00809708069124 ()
HH-1R09-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0R05-CA-00
In Commercial Distribution

  • 00809708064051 ()
HH-0R05-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
ALIMED, INC.
71326410
In Commercial Distribution

  • 00733657286632 ()
  • 00733657300529 ()
2970009212

  • Vulnerable patient home alert system
No Description
ALIMED, INC.
71098510
In Commercial Distribution

  • 00733657286069 ()
  • 00733657300291 ()
2970008689

  • Vulnerable patient home alert system
No Description
ALIMED, INC.
203210ML
In Commercial Distribution

  • 00733657285796 ()
  • 00733657300260 ()
2970000363

  • Vulnerable patient home alert system
No Description
ALIMED, INC.
203210
In Commercial Distribution

  • 00733657285789 ()
  • 00733657300253 ()
2970000362

  • Vulnerable patient home alert system
No Description
ALIMED, INC.
91-634
In Commercial Distribution

  • 00733657277432 ()
  • 00733657300031 ()
2970011683

  • Operating table torso positioner
Screwdriver SW3.5 cannulated
WITTENSTEIN intens GmbH
SCDR SW3.5 CA
Not in Commercial Distribution

  • 04260170140258 ()
60000406

  • Orthopaedic implant driver
BiPAP Auto, Canada
Respironics, Inc.
BiPAP Auto, CA
In Commercial Distribution

  • 00606959031715 ()
761CA

  • Home BPAP unit
REMstar Auto, Canada
Respironics, Inc.
REMstar Auto, CA
In Commercial Distribution

  • 00606959030527 ()
561CA

  • Home CPAP unit
REMstar Pro, Canada
Respironics, Inc.
REMstar Pro, CA
In Commercial Distribution

  • 00606959030138 ()
461CA

  • Home CPAP unit
DreamStation CPAP, Canada
Respironics, Inc.
DreamStation CPAP, CA
In Commercial Distribution

  • 00606959026520 ()
CAX200S12

  • Home CPAP unit
Dorma 200, Canada
Respironics, Inc.
Dorma 200, CA
In Commercial Distribution

  • 00606959038578 ()
CAV201

  • Heated respiratory humidifier
  • Home CPAP unit
Dorma 200, Canada
Respironics, Inc.
Dorma 200, CA
In Commercial Distribution

  • 00606959038455 ()
201VCA

  • Home CPAP unit
  • Heated respiratory humidifier
BiPAP Pro, Canada
Respironics, Inc.
BiPAP Pro, CA
In Commercial Distribution

  • 00606959031371 ()
661CA

  • Home BPAP unit
REMstar Plus, Canada
Respironics, Inc.
REMstar Plus, CA
In Commercial Distribution

  • 00606959030046 ()
261CA

  • Home CPAP unit
The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
7 day - CA
In Commercial Distribution

  • 04250903201127 ()
2067634-177

  • Electrocardiographic ambulatory recorder
The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
24 hour - CA
In Commercial Distribution

  • 04250903201080 ()
2067634-175

  • Electrocardiographic ambulatory recorder
The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
48 hour - CA
In Commercial Distribution

  • 04250903201103 ()
2067634-176

  • Electrocardiographic ambulatory recorder
TITAN-Periodontal Probe # CP15"North Ca" graduated; 1-2...-14-15 mm COMFORT | SL | single ended
devemed GmbH
02-2525-40 CT
In Commercial Distribution

  • 04061644039623 ()


  • Periodontal probe, reusable
TITAN-Periodontal Probe # CP15"North Ca" graduated; 1-2...-14-15 mm F-LINE | SL | single ended
devemed GmbH
2525-40 FT
In Commercial Distribution

  • 04061644039616 ()


  • Periodontal probe, reusable
NOVA CONTROL 3 Na+,K+,Cl-,Ca++,GLU,BUN, TCa,Mg++,Li+,pH
NOVA BIOMEDICAL CORPORATION
3
In Commercial Distribution

  • 00385480186544 ()
  • 00385489186545 ()
18654

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
BUR TREPHINE 23TL 7ID 7.9OD 6.75CL CA 6MM MARKINGS TI 6AL 4V ELI
ACE SURGICAL SUPPLY CO., INC.
04948602
In Commercial Distribution

  • 00614950011872 ()

  • Outer Diameter: 7.9 Millimeter
04948602

  • Titanium dental bur
ADMIN SET IV 68" CONVERT PIN W/FLASH BULB 15DPS/MIN 50/CA
ACE SURGICAL SUPPLY CO., INC.
0031400
In Commercial Distribution

  • 10614950009159 ()
  • 00614950009152 ()

  • Length: 68 Inch
0031400

  • Intravenous administration tubing extension set
WBP Home A BT (BP3MX1-3C) with Universal Label for USA/EU/CA markets
MICROLIFE USA, INC.
CRO-BP3MX1-3C1
In Commercial Distribution

  • 04719003315085 ()
  • 14719003315082 ()
  • 24719003315089 ()
  • 34719003315086 ()


  • Arrythmia-detection sphygmomanometer
DRAPE POLYTISSUE W/TIE 40X32 NS 12/PKG DISPOSABLE 5PKG/CA L/F
ACE SURGICAL SUPPLY CO., INC.
0034101
In Commercial Distribution

  • 10614950000095 ()
  • 00614950000098 ()

  • Length: 40 Inch
0034101

  • Patient surgical drape, single-use, non-sterile
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