Fisher & Paykel Healthcare Inc

6 devices in the database

  • Model / Serial
    Lot Numbers for Part Numbers: 400HC202 (lot #s: 040802 to 051222),400HC203 (lot #s: 040719 to 051103), 400HC209 (lot #s: 041108 to 050920), 400HC502 (lot #s: 040825 to 060201), 400HC503 (lot #s:040830 to 051028), 400HC505 (lot #s: 050223 to 050726), 400HCHC510 (lot #s: 051007 to 051028) , 900HC402 (lot #s: 010918 to 060203), 900HC405 (lot#s: 030924 to 030925), 900HC406 (lot #s: 031110 to 060403), 900HC412 (lot #s: 020108 to 060203), 900HC441 (lot #s: 031110 to 060424) & 900HC463 (lot #s: 020108 to 040604)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203 (Elbow + vent NR valve), 400HC209 (Oracle 452 flexitube kit vent NR), 400HC502 (HC407 mask no headgear), 400HC503 (HC431 mask no headgear), 400HC505 (Infinity HC481 mask base), 400HCHC510 (HC406 mask no headgear) , 900HC402 (Aclaim mask no headgear), 900HC405 (HC405 sleep lab mask kit), 900HC406 (HC405 mask no headgear), 900HC412 (Aclaim flexitube kit), 900HC441 (Elbow diffuser and swivel) & 900HC463 (HC451 flexitube kit). CPAP masks.
  • Model / Serial
    Lot numbers for Part Numbers: 900HC451 (lot #s: 011001 to 011016), 900HC451T (lot #s: 011024 to 020517), HC451A (lot #s: 020523 to 040907), HC452A (lot #s: 031215 to 060503) & HC452F (lot #s: 040719 to 041102)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC452F. CPAP masks.
  • Model / Serial
    Lot numbers for Part Numbers: HC481A (lot #s:050128 to 060506) & HC481SL (lot #s: 050608 to 060327)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks.
  • Model / Serial
    Lot numbers for Part Numbers: HC405A (lot #s: 020930 to 060410) , HC405SL (lot #s: 040225 to 040325), HC405U (lot #s: 030922 to 060217), HCHC406A (lot #s: 050830 to 060123), HC406SL (lot #s: 051021 to 051220), HC407A (lot #s: 031124 to 060207), HC407SL (lot #s: 040921 to 060202) & HC407U (lot #s: 040407 to 060113)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks.
  • Model / Serial
    Lot numbers for Part Numbers: HC401A (lot #s: 020521 to 060217) & 900HC401 (lot #s: 010829 to 020517)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks.
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3 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Fisher & Paykel Healthcare Inc, 22982 Alcalde Drive 101, Laguna Hills CA 92653
  • Source
    USFDA