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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SPU SmartVest Wrap® – Large
ELECTROMED, INC.
SW-36/44-1
In Commercial Distribution

  • B102060145S0600 ()
  • B102060154S0605 ()
SW-36/44-1

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest Wrap® – Medium
ELECTROMED, INC.
SW-30/36-1
In Commercial Distribution

  • B102060145S0500 ()
  • B102060154S0505 ()
SW-30/36-1

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest Wrap® – Small
ELECTROMED, INC.
SW-25/30-1
In Commercial Distribution

  • B102060145S0400 ()
  • B102060154S0405 ()
SW-25/30-1

  • Chest-oscillation airway secretion-clearing system vest
SPU SmartVest Wrap® – S-Small
ELECTROMED, INC.
SW-17/25-1
In Commercial Distribution

  • B102060145S0300 ()
  • B102060154S0305 ()
SW-17/25-1

  • Chest-oscillation airway secretion-clearing system vest
116 in. (295 cm) Microset - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-161XYBS
Not in Commercial Distribution

  • B101A120161XYBS1 ()
  • B101A120161XYBS0 ()


  • Electric infusion pump administration set, single-use
115 in. (290 cm) Microset - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-161XYB
Not in Commercial Distribution

  • B101A120161XYB1 ()
  • B101A120161XYB0 ()


  • Electric infusion pump administration set, single-use
130 in. (330 cm) Microset - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-161XPSV
Not in Commercial Distribution

  • B101A120161XPSV1 ()
  • B101A120161XPSV0 ()


  • Electric infusion pump administration set, single-use
110 in. (280 cm) Microset - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-161XPS
Not in Commercial Distribution

  • B101A120161XPS0 ()
  • B101A120161XPS1 ()


  • Electric infusion pump administration set, single-use
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
106 in. (269 cm) CMExpress Microbore Set For Use with the CMExpress® Infusion Pump
CME AMERICA LLC
A120-161C
Not in Commercial Distribution

  • B101A120161C1 ()
  • B101A120161C0 ()


  • Electric infusion pump administration set, single-use
120 in. (305 cm) Microset with Filter and Y Site - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160XYSF
Not in Commercial Distribution

  • B101A120160XYSF1 ()
  • B101A120160XYSF0 ()


  • Electric infusion pump administration set, single-use
130 in. (330 cm) Microset with Filter and Y Site - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160XYBF
Not in Commercial Distribution

  • B101A120160XYBF1 ()
  • B101A120160XYBF0 ()


  • Electric infusion pump administration set, single-use
110 in. (280 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160XSFK
Not in Commercial Distribution

  • B101A120160XSFK1 ()
  • B101A120160XSFK0 ()


  • Electric infusion pump administration set, single-use
134 in. (340 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160XSFE
Not in Commercial Distribution

  • B101A120160XSFE1 ()
  • B101A120160XSFE0 ()


  • Electric infusion pump administration set, single-use
12 in. (30 cm) Microset with Female Luer - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160XPSN
Not in Commercial Distribution

  • B101A120160XPSN1 ()
  • B101A120160XPSN0 ()


  • Electric infusion pump administration set, single-use
83 in. (210 cm) - blue stripe MicroSet For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160XPS
Not in Commercial Distribution

  • B101A120160XPS1 ()
  • B101A120160XPS0 ()


  • Electric infusion pump administration set, single-use
63 in. (159 cm) MicroSet with Needleless Y Sites For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160X2YB
Not in Commercial Distribution

  • B101A120160X2YB1 ()
  • B101A120160X2YB0 ()


  • Electric infusion pump administration set, single-use
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
80 in. (200 cm) Spike with Drip Chamber For Use with the CMExpress® Infusion Pump
CME AMERICA LLC
A120-160CYRV
Not in Commercial Distribution

  • B101A120160CYRV1 ()
  • B101A120160CYRV0 ()


  • Electric infusion pump administration set, single-use
80 in. (200 cm) Spike with Drip Chamber For Use with the CMExpress® Infusion Pump
CME AMERICA LLC
A120-160CYFRV
Not in Commercial Distribution

  • B101A120160CYFRV1 ()
  • B101A120160CYFRV0 ()


  • Electric infusion pump administration set, single-use
80 in. (200 cm) For Use with the CMExpress® Infusion Pump
CME AMERICA LLC
A120-160CY
Not in Commercial Distribution

  • B101A120160CY1 ()
  • B101A120160CY0 ()


  • Electric infusion pump administration set, single-use
80 in. (200 cm) For Use with the CMExpress® Infusion Pump
CME AMERICA LLC
A120-160CRV
Not in Commercial Distribution

  • B101A120160CRV1 ()
  • B101A120160CRV0 ()


  • Electric infusion pump administration set, single-use
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
80 in. (200 cm) For Use with the CMExpress® Infusion Pump
CME AMERICA LLC
A120-160C
Not in Commercial Distribution

  • B101A120160C1 ()
  • B101A120160C0 ()


  • Electric infusion pump administration set, single-use
128 in. (320 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-125XSE
Not in Commercial Distribution

  • B101A120125XSE1 ()
  • B101A120125XSE0 ()


  • Electric infusion pump administration set, single-use
115 in. (290 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-125XS
Not in Commercial Distribution

  • B101A120125XS1 ()
  • B101A120125XS0 ()


  • Electric infusion pump administration set, single-use
110 in. (280 cm) - blue stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-112XSFK
Not in Commercial Distribution

  • B101A120112XSFK1 ()
  • B101A120112XSFK0 ()


  • Electric infusion pump administration set, single-use
150 in. (380 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-003XYVA
Not in Commercial Distribution

  • B101A120003XYVA0 ()
  • B101A120003XYVA1 ()


  • Electric infusion pump administration set, single-use
83 in. (210 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-003XSNY
Not in Commercial Distribution

  • B101A120003XSNY1 ()
  • B101A120003XSNY0 ()


  • Electric infusion pump administration set, single-use
83 in. (210 cm) For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-003XSN
Not in Commercial Distribution

  • B101A120003XSN0 ()
  • B101A120003XSN1 ()


  • Electric infusion pump administration set, single-use
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
105 in. (270 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-164XESF
Not in Commercial Distribution

  • B101A100164XESF0 ()
  • B101A100164XESF1 ()


  • Electric infusion pump administration set, single-use
103 in. (260 cm) - blue stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XSL
Not in Commercial Distribution

  • B101A100163XSL0 ()
  • B101A100163XSL1 ()


  • Electric infusion pump administration set, single-use
~110 in. (280 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XSFL
Not in Commercial Distribution

  • B101A100163XSFL0 ()
  • B101A100163XSFL1 ()


  • Electric infusion pump administration set, single-use
94 in. (240 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XESV
Not in Commercial Distribution

  • B101A100163XESV0 ()
  • B101A100163XESV1 ()


  • Electric infusion pump administration set, single-use
85 in. (220 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XESF
Not in Commercial Distribution

  • B101A100163XESF0 ()
  • B101A100163XESF1 ()


  • Electric infusion pump administration set, single-use
94 in. (240 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XES
Not in Commercial Distribution

  • B101A100163XES0 ()
  • B101A100163XES1 ()


  • Electric infusion pump administration set, single-use
130 in. (330 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XEBS
Not in Commercial Distribution

  • B101A100163XEBS0 ()
  • B101A100163XEBS1 ()


  • Electric infusion pump administration set, single-use
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
90 in. (230 cm) - yellow stripe, For Use with the BodyGuard® Pump
CME AMERICA LLC
A100-163XE90S
Not in Commercial Distribution

  • B101A100163XE90S1 ()
  • B101A100163XE90S0 ()


  • Electric infusion pump administration set, single-use
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