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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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AirLife™ - 10889483569283

AirLife™ Adult Aerosol Mask Vinyl, Under-The-Chin Style High Concentration
AIRLIFE
001207
In Commercial Distribution

  • 30889483569287 ()
  • 10889483569283 ()
  • 10190752116368 ()
001207

  • Rebreathing oxygen face mask

Regent™ - 05415067042354

Mechanical Heart Valve Sizer Set
ST. JUDE MEDICAL, INC.
907
In Commercial Distribution

907

  • Heart valve annulus sizer, reusable

NA - 05415067042330

Mechanical Heart Valve Sizer Set
ST. JUDE MEDICAL, INC.
905
In Commercial Distribution

905

  • Heart valve annulus sizer, reusable

NA - 05415067042316

Mechanical Heart Valve Leaflet Tester
ST. JUDE MEDICAL, INC.
LT100
In Commercial Distribution

  • 15415067042313 ()
  • 05415067042316 ()
  • 05415067004772 ()
LT100

  • Heart valve prosthesis tester, single-use

Masters Series™ - 05415067042293

Replacement Holder/Rotators
ST. JUDE MEDICAL, INC.
M-RHR
In Commercial Distribution

M-RHR

  • Heart valve prosthesis holder, single-use

Regent™ - 05415067042279

Replacement Holder/Rotators
ST. JUDE MEDICAL, INC.
AG-RHR
In Commercial Distribution

AG-RHR

  • Heart valve prosthesis holder, single-use

Masters Series™ - 05415067042255

Replacement Holder/Rotators
ST. JUDE MEDICAL, INC.
AHP-RHR
In Commercial Distribution

AHP-RHR

  • Heart valve prosthesis holder, single-use

Masters Series™ - 05415067042231

Replacement Holder/Rotators
ST. JUDE MEDICAL, INC.
A-RHR
In Commercial Distribution

A-RHR

  • Heart valve prosthesis holder, single-use

Séguin™ - 05415067041951

Annuloplasty Ring Sizer Set
ST. JUDE MEDICAL, INC.
SAR-501
In Commercial Distribution

SAR-501

  • Heart valve annulus sizer, reusable

NA - 05415067041937

Rigid Saddle Ring Sizer Set
ST. JUDE MEDICAL, INC.
RSAR-507A
In Commercial Distribution

RSAR-507A

  • Heart valve annulus sizer, reusable
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