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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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A.C.E Blue - 00864918000305

Blue Light for the treatment of acne
PULSADERM LLC
PD9505
In Commercial Distribution

  • 00864918000305 ()


  • Red/blue light phototherapy unit

TelePatch Cardiac Monitor - 00862887000371

TelePatch CM PM700 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM700
Not in Commercial Distribution

  • 00862887000371 ()


  • Electrocardiographic ambulatory recorder

Decipher Holter Monitor - 00862887000364

Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM461
Not in Commercial Distribution

  • 00862887000364 ()


  • Electrocardiographic ambulatory recorder

Cardiac Monitor - 00862887000357

Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM500
Not in Commercial Distribution

  • 00862887000357 ()


  • Electrocardiographic ambulatory recorder

CardioPAL SAVI - 00862887000340

CardioPAL SAVI is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM410
Not in Commercial Distribution

  • 00862887000340 ()


  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094212464

TAGCONNECT SOFTWARE AND SMART CABLE
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094212464 ()
TAGECG-SW

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094257786

H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Multiple languages and CD manual (except Brazilian Portuguese); AHA 5 wire, 27 in. (69cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094257786 ()
H3PLUS-CAA-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094246896

TAGECG WEARABLE SENSOR
WELCH ALLYN, INC.
901098
In Commercial Distribution

  • 00732094212471 ()
  • 00732094246896 ()
TAGECG-1

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094309300

Reconditioned H12+ 12-lead digital Holter Recorder - 24-hour with HF (high fidelity) for 24-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094309300 ()
H12PLUS-JPA-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094309294

Reconditioned H12+ 12-lead digital Holter Recorder - 24-hour with HF (high fidelity) for 24-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); IEC 10-wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094309294 ()
H12PLUS-JPB-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094309287

Reconditioned H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidelity) for 30-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094309287 ()
H12PLUS-KPA-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094309270

Reconditioned H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidelity) for 30-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); IEC 10-wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094309270 ()
H12PLUS-KPB-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094296358

TAGECG SMART CABLE
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094296358 ()
TAGECG-SMCABLE

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094296334

TAGconnect Software
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094296334 ()
TAGECG-SWF

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094294118

H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidelity) for 30-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 38"" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094294118 ()
H12PLUS-HPA-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094282498

2 channel patient cable for Vison 5L recorder
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094282498 ()
010-1726-00

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094275841

HOOKUP KIT MONITORING 10E SINGLE
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094275841 ()
9294-009-50

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094275834

Holter Hook Up Kit with Prep Items, Patient Diary, 10 electrodes and 1 AA Lithium Battery, Single Kit
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094275834 ()
9294-011-50

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094334944

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094334944 ()
RSCRIBE-6CC-AXDBA

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328868

H12+ Standard 12-lead digital Holter Recorder - 24-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); IEC 10-wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328868 ()
H12PLUS-LPB-XXXXX

  • Electrocardiographic ambulatory recorder
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