Device Recall EndoVive 3s Low Profile Balloon Kits

  • Model / Serial
    Part Number: M00548270 (XMD P/N 70-0050-612)  Lot Number: 929603
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548270 || (XMD P/N 70-0050-612) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Xeridiem Mediem Medical Devices Inc, 4700 S Overland Dr, Tucson AZ 85714-3430
  • Source
    USFDA

103 devices with a similar name

Learn more about the data here

  • Model / Serial
    Part Number: M00548340 (XMD P/N 70-0050-114)  Lot Numbers: 911105 915905 920605 928906 930863
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548340 || (XMD P/N 70-0050-114) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
  • Model / Serial
    Part Number: M00548460 (XMD P/N 70-0050-D14)  Lot Number: 929614
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548460 || (XMD P/N 70-0050-D14) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
  • Model / Serial
    Part Number: M00548330 (XMD P/N 70-0050-014)  Lot Numbers: 928905 930835
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548330 || (XMD P/N 70-0050-014) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
  • Model / Serial
    Part Number: M00548220 (XMD P/N 70-0050-112)  Lot Numbers: 911102 915402 915902 919001 920602 928902 930823
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548220 || (XMD P/N 70-0050-112) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
  • Model / Serial
    Part Number: M00548500 (XMD P/N 70-0050-116)  Lot Numbers: 928913
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548500 || (XMD P/N 70-0050-116) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
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