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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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SPERMCARE / SPERM WASH - Gradient System - 10859268006241

SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Lower Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures. SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
INVITROCARE, INCORPORATED
2224
In Commercial Distribution

  • 10859268006241 ()
2224

  • IVF medium

HUMAN SERUM ALBUMIN - 10859268006128

HUMAN SERUM ALBUMIN consists of human serum albumin from therapeutic-grade source material at a concentration of 100mg/ml in a sterile saline solution. HUMAN SERUM ALBUMIN is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth and embryo cryopreservation.
INVITROCARE, INCORPORATED
2101
In Commercial Distribution

  • 10859268006128 ()
2101

  • IVF medium

SPERM WASH MEDIUM - 10859268006043

SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
INVITROCARE, INCORPORATED
2003
In Commercial Distribution

  • 10859268006043 ()
2003

  • IVF medium

REDUX - 10855683006392

Redux Electrolyte Crème, 4 oz. Tube
PARKER LABORATORIES INC
ELECTROLYTE CREME
In Commercial Distribution

  • 10855683006392 ()
  • 00855683006395 ()
  • 20855683006399 ()
66-04

  • Electrode conductive medium

SpermFreeze SSP - 05411967005697

SpermFreeze SSP (50ml in PETG bottle) is a medium for freezing human sperm. SpermFreeze has a shelf life of 18 months.
Fertipro NV
SSP050
In Commercial Distribution

  • 05411967005703 ()
  • 05411967005697 ()

  • Total Volume: 50 Milliliter


  • IVF medium

SpermFreeze SSP - 05411967003440

SpermFreeze SSP SpermFreeze SSP is a medium for freezing human sperm. SpermFreeze has a shelf life of 18 months.
Fertipro NV
SSP62.5
Not in Commercial Distribution

  • 05411967003457 ()
  • 05411967003440 ()

  • Total Volume: 62.5 Milliliter


  • IVF medium

VitriThaw - 05411967002139

VitriThaw™ Thawing 4 (REF: VT4001) (1 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) . For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Fertipro NV
VT4001
In Commercial Distribution

  • 05411967002139 ()

  • Total Volume: 1 Milliliter


  • IVF medium

VitriThaw - 05411967002122

VitriThaw™ Thawing 3 (REF: VT3001) (3 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) . For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Fertipro NV
VT3001
In Commercial Distribution

  • 05411967002122 ()


  • IVF medium

VitriThaw - 05411967002115

VitriThaw™ Thawing 2 (REF: VT2001) (1 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) . For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Fertipro NV
VT2001
In Commercial Distribution

  • 05411967002115 ()

  • Total Volume: 1 Milliliter


  • IVF medium

VitriThaw - 05411967002108

VitriThaw™ Thawing 1 (REF: VT1005) (5 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) . For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Fertipro NV
VT1005
In Commercial Distribution

  • 05411967002108 ()

  • Total Volume: 5 Milliliter


  • IVF medium
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