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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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PRESEP OXIMETRY CATHETER SET 8.5F 20CM
Edwards Lifesciences LLC
X3820S
In Commercial Distribution

  • 00690103163384 ()

  • EXTERIOR DIAMETER: 8.5 F (2.8 MM), USABLE LENGTH: 20 CM, NUMBER OF LUMENS: 3, RECOMMENDED GUIDEWIRE SIZE: 0.032" (0.81 MM)
X3820S

  • Oximeter catheter, single-use
NON-BALLOON DUAL LUMEN OXIMETRY CATHETER
Edwards Lifesciences LLC
040F4
In Commercial Distribution

  • 00690103000221 ()

  • EXTERIOR DIAMETER: 4F (1.33MM), USABLE LENGTH: 40CM, RECOMMENDED GUIDEWIRE SIZE: 0.016 IN (0.41 MM), MINIMUM INTRODUCER SIZE: 4.5F (1.50 MM)
040F4

  • Oximeter catheter, single-use
NON-BALLOON DUAL LUMEN OXIMETRY CATHETER
Edwards Lifesciences LLC
015F4
In Commercial Distribution

  • 00690103000207 ()

  • EXTERIOR DIAMETER: 4F (1.33MM), USABLE LENGTH: 25CM, RECOMMENDED GUIDEWIRE SIZE: 0.016 IN (0.41 MM), MINIMUM INTRODUCER SIZE: 4.5F (1.50 MM)
015F4

  • Oximeter catheter, single-use
Product consist of piercing spike and cover, the twist off-connector and an integrated vial adaptor for access to drugs/solution vials. Indicated to serve as a connecting port between IV bag and external IV line.
DRAGON HEART MEDICAL, INC.
R002
Not in Commercial Distribution

  • B346R0021 ()
R002

  • Electronic gravity infusion controller administration set
No Description
BQ PLUS MEDICAL CO., LTD.
SS300
In Commercial Distribution

  • 26972620115762 ()


  • Electronic gravity infusion controller administration set
Epithelium Well 8.5mm
Beaver-Visitec International, Inc.
MMSU1197S
In Commercial Distribution

  • 05055186206444 ()
  • 35055186206445 ()
MMSU1197S

  • LASEK alcohol well, single-use
No Description
BQ PLUS MEDICAL CO., LTD.
S-BS-002D
In Commercial Distribution

  • 06972620118004 ()


  • Electronic gravity infusion controller administration set
No Description
BQ PLUS MEDICAL CO., LTD.
SS300
In Commercial Distribution

  • 06972620115744 ()


  • Electronic gravity infusion controller administration set
No Description
BQ PLUS MEDICAL CO., LTD.
S-LS-002D
In Commercial Distribution

  • 06972620112293 ()


  • Electronic gravity infusion controller administration set
No Description
BQ PLUS MEDICAL CO., LTD.
S-LS-000D
In Commercial Distribution

  • 06972620112279 ()


  • Electronic gravity infusion controller administration set
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