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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. - 00732094264838

H12+ 12-lead digital Holter Recorder - 48-hour (requires AA Lithium battery), includes standard compact flash card (128 MB), carry case, , and hookup kit; English language and CD manual; IEC 10-wire, 12-lead LeadForm 38 in. (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094264838 ()
H12PLUS-BAB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094262933

Surveyor Central Additional Control - configured CPU English language and CD manual; 220V power; 16 monitoring slots (dual or 24 in. display required with additional CPU); No printer; Dual color LCD 24 in. monitors with high resolution and dual stand
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262933 ()
SCAC-AAB-CXDXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262926

Surveyor Central Additional Control - configured CPU English language and CD manual; 220V power; 24 monitoring slots (dual or 24 in. display required with additional CPU); No printer; Dual color LCD 24 in. monitors with high resolution and dual stand
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262926 ()
SCAC-AAB-DXDXX

  • Centralized patient monitor

BPMS Evolution - B970BCE531510

Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5315 Sensors with Sensor Cover, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5315 Sensors)
In Commercial Distribution

  • B970BCE531510 ()
BCE5315-1

  • Body-surface pressure mapping system

Norav 1200 Series PC-ECG - 07290110252601

Norav 1200 Series PC-ECG Software Kit (COSMED) with the following Option(s): - D1 = ECG Management System NEMS - S2 = Advanced Stress-Test ECG - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I2-D1
In Commercial Distribution

  • 07290110252601 ()
HASP-SW-K-S2I2D1-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer
  • Patient-administration information system application software

Welch Allyn, Inc. - 00732094294101

RScribe 12-Lead Multi-Channel Electrocardiograph - version 7, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; No patient cable; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
Not in Commercial Distribution

  • 00732094294101 ()
RSCRIBE-7EC-XXDXA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263091

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; International power cord; No printer; Suction electrodes (6) and clamps (4); IEC 10 wire, 12-lead lead set with banana plugs; No connectivity
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263091 ()
RSCRIBE-6CC-DXCBX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263015

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; No patient cable; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263015 ()
RSCRIBE-6EC-XXDXA

  • Electrocardiograph, professional, multichannel

TM "Soloventex" 550-241 L Left - 04823097718124

It is a monostocking with an adjustable belt with an open toe, 2nd compression class 23-32 mm. Hg., black color, tight structure, made of elastane and polyamide. The compression effect of the knitwear causes the following therapeutic effects: narrows the lumen of the veins, increases the rate of venous blood outflow, prevents its stagnation, normalizes the activity of the muscular-venous pump; prevents the formation of blood clots; protects the legs from edema, fatigue and pain.
REABILITIMED TOV
550-241 L Left
In Commercial Distribution

  • 04823097718124 ()

  • Pressure: 23-32 mm. Hg.
  • Circumference (cm): cB 25,5-27,5; cC 37,0-43,0; cD 37,0-42,0; cG 55,0-62,0; cT 90-120
  • Lenght (cm): lG 74,1-83,0
550-241 L Left

  • Compression/pressure sock/stocking, single-use

TM "Soloventex" 550-231 XXL Right - 04823097718117

It is a monostocking with an adjustable belt with an open toe, 2nd compression class 23-32 mm. Hg., black color, dense structure, made of elastane and polyamide. The compression effect of the knitwear causes the following therapeutic effects: narrows the lumen of the veins, increases the rate of venous blood outflow, prevents its stagnation, normalizes the activity of the muscular-venous pump; prevents the formation of blood clots; protects the legs from swelling, fatigue and pain.
REABILITIMED TOV
550-231 XXL Right
In Commercial Distribution

  • 04823097718117 ()

  • Pressure: 23-32 mm. Hg.
  • Circumference (cm): cB 31,5-34,0; cC 45,0-53,0; cD 43,0-49,0; cG 65,0-71,0; cT 105-135
  • Lenght (cm): lG 83,1-92,0
550-231 XXL Right

  • Compression/pressure sock/stocking, single-use
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