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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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Isolation Gown Universal Size AAMI Level 2 Over-the-head Elastic Wrist + Thumbhook Yellow This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Cardinal Health 200, LLC
AT4488-BD
In Commercial Distribution

  • 50885380152304 ()
  • 20885380152303 ()
  • 10885380152306 ()
AT4488-BD

  • Isolation gown, single-use
Kit includes: PC-ECG 1200W (UDI: 04260498565054) wireless Stress-Test Kit (Rev.02); PC-ECG 1200WR (UDI: 04260498566907) Receiver Unit Input cable with ten leads AHA type and Clip connectors. Special edition for GE Health Care.
Norav Medical GmbH
1200W Kit
In Commercial Distribution

  • 04260498566921 ()
1200W2-K-04-U-C10-03

  • Electrocardiographic signal amplifier
Kit includes: PC-ECG 1200W (UDI: 04260498565047) wireless Stress-Test Kit (Rev.02); PC-ECG 1200WR (UDI: 04260498566907) Receiver Unit Input cable with ten leads IEC type and Clip connectors. Special edition for GE Health Care.
Norav Medical GmbH
1200W Kit
In Commercial Distribution

  • 04260498566914 ()
1200W2-K-04-E-C10-03

  • Electrocardiographic signal amplifier
Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling and administration. This device is non-sterile and for single use only.
COPIOUMED INTERNATIONAL INC.
CTN3B304-1
In Commercial Distribution

  • 14719882251778 ()
  • 04719882251771 ()
  • 04719882251764 ()


  • Isolation gown, single-use
Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling and administration. This device is non-sterile and for single use only.
COPIOUMED INTERNATIONAL INC.
CTN3B303-1
In Commercial Distribution

  • 14719882251754 ()
  • 04719882251757 ()
  • 04719882251740 ()


  • Isolation gown, single-use
Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling and administration. This device is non-sterile and for single use only.
COPIOUMED INTERNATIONAL INC.
CTN3B302-1
In Commercial Distribution

  • 14719882251730 ()
  • 04719882251733 ()
  • 04719882251726 ()


  • Isolation gown, single-use
Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling and administration. This device is non-sterile and for single use only.
COPIOUMED INTERNATIONAL INC.
CTN3B301-1
In Commercial Distribution

  • 14719882251716 ()
  • 04719882251719 ()
  • 04719882251702 ()


  • Isolation gown, single-use
Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling and administration. This device is non-sterile and for single use only.
COPIOUMED INTERNATIONAL INC.
CTN3B204-1
In Commercial Distribution

  • 14719882251617 ()
  • 04719882251610 ()
  • 04719882251603 ()


  • Isolation gown, single-use
Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling and administration. This device is non-sterile and for single use only.
COPIOUMED INTERNATIONAL INC.
CTN3B203-1
In Commercial Distribution

  • 14719882251594 ()
  • 04719882251597 ()
  • 04719882251580 ()


  • Isolation gown, single-use
Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling and administration. This device is non-sterile and for single use only.
COPIOUMED INTERNATIONAL INC.
CTN3B202-1
In Commercial Distribution

  • 14719882251570 ()
  • 04719882251573 ()
  • 04719882251566 ()


  • Isolation gown, single-use
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