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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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DRUGS OF ABUSE LEVEL 5
UTAK LABORATORIES, INC.
DAU 5 F LE
In Commercial Distribution

  • B800DAU5FLE5 ()
  • B800DAU5FLE0 ()

  • Total Volume: 12 Milliliter
DAU 5 F LE

  • Multiple drugs of abuse IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 5 V2
UTAK LABORATORIES, INC.
ISA+ CAL 5 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL5V2SFUCSF5 ()
  • B800ISACAL5V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 5 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
HIOSSEN, INC.
FNLHYD05
In Commercial Distribution

  • 00810126042019 ()


  • Dental implant suprastructure, temporary, preformed, single-use
CS5+,110V ENG, LN02005-110-EP
HAEMONETICS CORPORATION
02005-110-EP
In Commercial Distribution

  • 30812747016814 ()


  • Autotransfusion system blood collection/processing pump
No Description
Acuitive Technologies, Inc.
30-102-0515
In Commercial Distribution

  • 00810027270207 ()
30-102-0515

  • Tendon/ligament bone anchor, bioabsorbable
No Description
Acuitive Technologies, Inc.
30-102-0510
In Commercial Distribution

  • 00810027270191 ()
30-102-0510

  • Tendon/ligament bone anchor, bioabsorbable
Freevent XtraCare and Freevent XtraCare Mini are single use Heat and Moisture Exchangers with electrostatic filters (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma
Atos Medical AB
7789
In Commercial Distribution

  • 07331791016578 ()
  • 07331791008979 ()
7789

  • Tracheostoma protective filter
Freevent XtraCare and Freevent XtraCare Mini are single use Heat and Moisture Exchangers with electrostatic filters (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma
Atos Medical AB
7788
In Commercial Distribution

  • 07331791016561 ()
  • 07331791008962 ()
7788

  • Tracheostoma protective filter
Provox Micron HME is a disposable device that features a calcium chloride-treated foam core in a plastic housing. Provox Micron HME also contains an electrostatic filter material which reduces airborne particles. The filter consists of synthetic fibres which, during the manufacturing process, generate electrical charges on the fibre surface. The result is a highly stable, coarse fibred electrostatic filter media with high efficiency against sub-micron particles and low air flow resistance.The housing of Provox Micron HME can be pressed down to occlude the stoma in order to speak with a voice prosthesis. When the pressure is released, the housing automatically retracts and opens the airway passage.
Atos Medical AB
7247
In Commercial Distribution

  • 07331791001550 ()
  • 07331791010590 ()
  • 07331791017766 ()
7247

  • Tracheostoma protective filter
No Description
Maquet Critical Care AB
6887050
In Commercial Distribution

  • 07325710009796 ()


  • Neonatal/adult intensive-care ventilator
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