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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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Belotero Balance - M2138700M05

Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. Belotero Balance kit contains (1) injectable implant and 2 needles - 30 Gauge x 1/2 inch, and 27 Gauge x 1/2 inch.
MERZ NORTH AMERICA, INC.
8700M0
Not in Commercial Distribution

  • M2138700M05 ()

  • Total Volume: 1 Milliliter


  • Dermal tissue reconstructive material, microbe-derived

Ventlab - 10889483085790

INFANT AIRFLOW W/MANOMETER AND 2 MASKS
VENTLAB, LLC
AF3100MB-M01
In Commercial Distribution

  • 20889483085797 ()
  • 10889483085790 ()

  • Total Volume: 300 Milliliter


  • Pulmonary resuscitator, manual, single-use

Ventlab - 10889483102138

PEDI,MANOMETER,PEEP ATTACHED,14',SOFT
VENTLAB, LLC
AF2100MB-PWTS4
In Commercial Distribution

  • 20889483102135 ()
  • 10889483102138 ()

  • Total Volume: 1000 Milliliter


  • Pulmonary resuscitator, manual, single-use

EXPRESS FLUID WARMER DISPOSABLE - M535FWS3090

No Description
NXSTAGE MEDICAL, INC.
FWS-309
In Commercial Distribution

  • M535FWS3090 ()
  • M535FWS3095 ()


  • Conduction blood/fluid warmer set

EXPRESS FLUID WARMER DISPOSABLE - M535FWS3080

No Description
NXSTAGE MEDICAL, INC.
FWS-308
In Commercial Distribution

  • M535FWS3080 ()
  • M535FWS3085 ()


  • Conduction blood/fluid warmer set

EXPRESS FLUID WARMER DISPOSABLE - M535FWS3050

No Description
NXSTAGE MEDICAL, INC.
FWS-305
In Commercial Distribution

  • M535FWS3050 ()
  • M535FWS3055 ()


  • Conduction blood/fluid warmer set

EXPRESS FLUID WARMER DISPOSABLE - M535FWS3040

No Description
NXSTAGE MEDICAL, INC.
FWS-304
In Commercial Distribution

  • M535FWS3040 ()
  • M535FWS3045 ()


  • Conduction blood/fluid warmer set

COMFORTMATE FLUID WARMER DISPOSABLE - M535FWS209B0

No Description
NXSTAGE MEDICAL, INC.
FWS-209-B
In Commercial Distribution

  • M535FWS209B0 ()
  • M535FWS209B5 ()


  • Conduction blood/fluid warmer set

COMFORTMATE FLUID WARMER DISPOSABLE - M535FWS206B0

No Description
NXSTAGE MEDICAL, INC.
FWS-206-B
In Commercial Distribution

  • M535FWS206B0 ()
  • M535FWS206B5 ()


  • Conduction blood/fluid warmer set

Radiesse (+) Lidocaine - M2138063M0K25

Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (2) 1.5cc Injectable Implant and (4) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8063M0K2
In Commercial Distribution

  • M2138063M0K25 ()
  • M2138063M0K22 ()

  • Total Volume: 3.0 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
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