Medela Inc

9 dispositifs dans la base de données

  • Modèle / numéro de série
    manufacture dates 02/10/10 through 03/03/10
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, including Puerto Rico
  • Description du dispositif
    Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the affected breast pumps were sold in the following configurations: || a) article 57027 - Kit PNSA Shoulder Bag; || b) article 57027T - Kit PNSA Shoulder Bag Tagged; || c) article 57036T - Kit PNSA The Metro Bag Tagged; || d) article 57043 - PNSA without kit; || e) article 57062 - Kit PNSA Backpack; || f) article 57062-03 - Kit PNSA Backpack CA/3; || g) article 57062T - Kit PNSA Backpack Tagged; || h) 57102 - Motor Replacement PNSA Backpack 57062; || i) 57103 - Motor Replacement PNSA Shoulder Bag 57027 || Intended use: A powered breast pump for the removal, collection and storage of mother's breast milk.
  • Modèle / numéro de série
    item #1908095, revision B 0909, contained in kits shipped between 10/23/09 and 02/02/2010
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution
  • Description du dispositif
    Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user accessory kits for use with Symphony breast pumps: || a) Model 67023, Harmony to Symphony Conversion Kit; || b) Model 67091, Lactina to Symphony Conversion Retail Kit; || c) Model 67099, Symphony Retail Kit; || d) Model 67099-06, Symphony Retail Kit - case of 6 kits; || e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts;
  • Modèle / numéro de série
    product code 0877061, lot 370118, some of which were mislabeled as product 0877067, lot 370118
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of California, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Mississippi, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee and Texas.
  • Description du dispositif
    Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. || Medela Healthcare, || McHenry, IL 60051; || A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case; || Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit, 15 Fr Round Channel Drain, product 0877067, lot 370118
  • Modèle / numéro de série
    article number 67203S, lot numbers 358789, 359716, 360440, 360632, 364515, 366388, 366492, 366570, 366682, 366702, 366705, and 366806.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, MA, MD, ME,MI, MN, MS, MT, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TX, UT, VA, VT, WA, WI, and WV.
  • Description du dispositif
    Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S || Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby.
  • Modèle / numéro de série
    Article #9207010 Transformer (The transformer can be found as an individual item shipped with the products listed below) a) 57018W Kit PNSA W/O Bat PK WIC b) 57027 Kit PNSA Shoulder Bag c) 57027-03 Kit PNSA Shoulder Bag CS/3 d) 57027POP Display PNSA e) 57027T Kit PNSA w/Battery Pack f) 57036 Kit PNSA Metro g) 57036-03 Kit PNSA Black Metro h) 57036T 57036-03 Metro Tagged i) 57038 Pump ADV POP Medical Ast. j) 57043 57043 PNSA Without Kit k) 57045W Kit PNSA W/BAT PK WIC l) 57045WT KIT PNSA WIC W/BAT PK m) 57046 PNSA Tote without Kit n) 57062 Kit PNSA Backpack o) 57062-03 Kit PNSA Backpack CAl3 p) 57062T Kit PNSA Tagged Backpack q) 57063 PNSA Tote r) 57063-03 PNSA Tote 3-Pack s) 57063T PNSA Tote Tagged t) 6007113 Kit Motor Replacement Metro 2008
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution and Puerto Rico and countries of Canada, Bermuda, Cayman Islands, Hong Kong and Haiti. CHI-DO proposes phone call audit checks of 2 consumers, 2 retailers and 1 hospital account by each district.
  • Description du dispositif
    AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010. || Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps.
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  • Adresse du fabricant
    Medela Inc. EF Division, 785 Challenger St, Brea CA 92821-2948
  • Source
    USFDA