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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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Rescuer O-Mask Oxygen Mask with Universal Tubing - B0026210U0

Rescuer O-Mask Oxygen Mask with Universal Tubing (Child)
B.L.S. Systems Limited
6210-U
In Commercial Distribution

  • B0026210U7 ()
  • B0026210U0 ()
  • B0026210U9 ()

  • Child
6210-U

  • Non-rebreathing oxygen face mask

Rescuer BVM Manual Resuscitator with Universal Tubing - B0024000U0

Rescuer Adult disposable manual resuscitator with 2900 Ml reservoir, #5 cushion mask and 2 m crush proof oxygen tubing with universal style connector
B.L.S. Systems Limited
4000U
In Commercial Distribution

  • B0024000U0 ()
  • B0024000U3 ()

  • Adult
4000U

  • Pulmonary resuscitator, manual, single-use

CMExpress® Microbore Set with Needleless Y-Site - B101A120161CYF0

105 in. (267 cm) CMExpress® Microbore Set w/ Needleless Y-Site For Use with the CMExpress® Infusion Pump
CME AMERICA LLC
A120-161CYF
Not in Commercial Distribution

  • B101A120161CYF1 ()
  • B101A120161CYF0 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Microset with compression fit adapter - B101A120160GCFA0

80 in. (200 cm) BodyGuard® Fluid Transfer MicroSet, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160GCFA
Not in Commercial Distribution

  • B101A120160GCFA0 ()
  • B101A120160GCFA1 ()


  • Electric infusion pump administration set, single-use

CMExpress® Set with Needleless Y Sites - B101A120160C2YRV0

95 in. (240 cm) For Use with the CMExpress® Infusion Pump
CME AMERICA LLC
A120-160C2YRV
Not in Commercial Distribution

  • B101A120160C2YRV1 ()
  • B101A120160C2YRV0 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Set with Needleless Y Sites - B101A120003XS2YV0

115 in. (290 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-003XS2YV
Not in Commercial Distribution

  • B101A120003XS2YV0 ()
  • B101A120003XS2YV1 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Microset with Male Luer Connectors - B101A100163XEBF0

130 in. (330 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XEBF
Not in Commercial Distribution

  • B101A100163XEBF0 ()
  • B101A100163XEBF1 ()


  • Electric infusion pump administration set, single-use

BRAEBON Ultima Snoring Sensor with Keyhole Connector - B14005430

For use during sleep disorder studies as a measure of snoring for recording onto a data acquisition system.
Braebon Medical Corporation
0543
In Commercial Distribution

  • B14005430 ()
0543

  • Freestanding microphone

FlexGuard Laser Fiber with Extended Length Sheath - B14527750300U1SH0

300 micrometer FlexGuard fiber with extended length sheath
OPTICAL INTEGRITY INC
27750300U1SH
Not in Commercial Distribution

  • B14527750300U13SH1 ()
  • B14527750300U1SH0 ()

  • fiber core diameter
  • Outer Diameter: 300 Micrometer


  • General/multiple surgical laser system beam guide, reusable

FlexGuard Laser Fiber with Extended Length Sheath - B14527750272U1SH0

272 micrometer FlexGuard fiber with extended length sheath
OPTICAL INTEGRITY INC
27750272U1SH
Not in Commercial Distribution

  • B14527750272U13SH1 ()
  • B14527750272U1SH0 ()

  • fiber core diameter
  • Outer Diameter: 272 Micrometer


  • General/multiple surgical laser system beam guide, reusable
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