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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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Welch Allyn, Inc. - 00732094265057

E-Scribe ECG Data Management Workstation - Enterprise system, floating; English system language; 110V power; Tower workstation computer hardware (no keyboard, mouse, or display);
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094265057 ()
ESWKST-DAA-AXXXX

  • Patient health record information system application software

WalkLink System ((Clinician Kit) - 00858184006062

Provides a wireless connection between the WalkAide and a computer, and also allows manual stimulation during walking trials via the Hand Switch.
INNOVATIVE NEUROTRONICS, INC.
20-0300
In Commercial Distribution

  • 00858184006062 ()


  • Gait-enhancement electrical stimulation system, external

WalkLink Unit - 00858184006055

Provides a wireless connection between the WalkAide and a computer, and also allows manual stimulation during walking trials via the Hand Switch.
INNOVATIVE NEUROTRONICS, INC.
20-0310
In Commercial Distribution

  • 00858184006055 ()


  • Gait-enhancement electrical stimulation system, external

SENSIMED Triggerfish® Software - 07640153470157

Computer software for the configuration of SENSIMED Triggerfish® monitoring session and subsequent downloading, display and analysis of data from these sessions
Sensimed SA
V3
In Commercial Distribution

  • 07640153470157 ()
ST8000

  • Ocular volume ambulatory recording system software

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

Welch Allyn, Inc. - 00732094328851

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); AHA 10 wire, 12-lead LeadForm 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328851 ()
H12PLUS-LPC-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328844

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 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328844 ()
H12PLUS-LPD-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328837

H12+ Standard 12-lead digital Holter Recorder - 48-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

  • 00732094328837 ()
H12PLUS-MPB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328820

H12+ Standard 12-lead digital Holter Recorder - 48-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328820 ()
H12PLUS-MPC-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328813

H12+ Standard 12-lead digital Holter Recorder - 48-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 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328813 ()
H12PLUS-MPD-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328806

H12+ High Fidelity 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

  • 00732094328806 ()
H12PLUS-NPB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328790

H12+ High Fidelity 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); AHA 10 wire, 12-lead LeadForm 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328790 ()
H12PLUS-NPC-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328783

H12+ High Fidelity 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 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328783 ()
H12PLUS-NPD-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328776

H12+ High Fidelity 12-lead digital Holter Recorder - 48-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

  • 00732094328776 ()
H12PLUS-OPB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328769

H12+ High Fidelity 12-lead digital Holter Recorder - 48-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328769 ()
H12PLUS-OPC-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328752

H12+ High Fidelity 12-lead digital Holter Recorder - 48-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 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328752 ()
H12PLUS-OPD-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094327793

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); AHA 10 wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends;
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094327793 ()
H12PLUS-LPA-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094327786

H12+ Standard 12-lead digital Holter Recorder - 48-hour, includes secure digital (SD) card, 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

  • 00732094327786 ()
H12PLUS-MPA-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094327779

H12+ High Fidelity 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); AHA 10 wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends;
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094327779 ()
H12PLUS-NPA-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094327762

H12+ High Fidelity 12-lead digital Holter Recorder - 48-hour, includes secure digital (SD) card, 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

  • 00732094327762 ()
H12PLUS-OPA-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094327410

H12 V5.0 USER MANUALS
WELCH ALLYN, INC.
901141
Not in Commercial Distribution

  • 00732094327410 ()
9515-160-51-CD

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094320701

H3+ 3-channel digital Holter Recorder - 48-hour, includes carry case with clip, and hookup kit (available for US only)
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094320701 ()
H3PLUS-BAB-XXXXX

  • 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. - 00732094308563

H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Brazilian Portugese INMETRO labeling, language, and CD manual; AHA 5 wire, 15" (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094308563 ()
H3PLUS-COD-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094308556

H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Brazilian Portugese INMETRO labeling, language, and CD manual; IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094308556 ()
H3PLUS-COE-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094296358

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

  • 00732094296358 ()
TAGECG-SMCABLE

  • Electrocardiographic ambulatory recorder
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