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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Bite Block, O2-CO2 monitoring and oxygen delivery, with strap
KEY SURGICAL, INC.
EN-315
Not in Commercial Distribution

  • 00849771043843 ()
  • 00849771037200 ()
EN315

  • Endoscopic bite block, oxygenating
No Description
BIOTRONIK SE & Co. KG
Smart 3G
In Commercial Distribution

  • 04035479139360 ()
401831

  • Patient monitoring modem
No Description
Merit Medical Systems, Inc.
10884450122782
In Commercial Distribution

  • 20884450122789 ()
  • 10884450122782 ()
  • 00884450122785 ()

  • Blade Length-110 mm
TIO60-110

  • Endoscopic bite block, oxygenating
No Description
Merit Medical Systems, Inc.
10884450122775
In Commercial Distribution

  • 20884450122772 ()
  • 10884450122775 ()
  • 00884450122778 ()

  • Blade Length-100 mm
TIO60-100

  • Endoscopic bite block, oxygenating
No Description
Merit Medical Systems, Inc.
10884450122768
In Commercial Distribution

  • 20884450122765 ()
  • 10884450122768 ()
  • 00884450122761 ()

  • Blade Length-90 mm
TIO60-90

  • Endoscopic bite block, oxygenating
LATITUDE ® Communicator
BOSTON SCIENTIFIC CORPORATION
6482
In Commercial Distribution

  • 00802526580802 ()


  • Patient monitoring modem
LATITUDE ® Communicator with Wand
BOSTON SCIENTIFIC CORPORATION
6481
In Commercial Distribution

  • 00802526580727 ()


  • Patient monitoring modem
Arterial Blood Collection Kit, 48", 6cc, w/o DPT
UTAH MEDICAL PRODUCTS, INC.
Custom
In Commercial Distribution

  • H6719026351 ()
  • H6719026350 ()

  • Total Volume: 6 Milliliter
  • Length: 48 Inch
902-635

  • Vascular catheter flush valve, continuous
  • In-line arterial blood sampling set
Arterial Blood Collection Kit w/o Transducer
UTAH MEDICAL PRODUCTS, INC.
Custom
In Commercial Distribution

  • H6719026271 ()
  • H6719026270 ()
902-627

  • Vascular catheter flush valve, continuous
  • In-line arterial blood sampling set
The Inflatable Dount Pessary is effective support in second- or third-degree prolapsed, and also effective in patients with mild cystocele or rectocele associated with a procidentia/prolapsed.
PANPAC MEDICAL CORPORATION
ID2
In Commercial Distribution

  • 04715309122259 ()


  • Bladder-supporting pessary
No Description
Bioteque Taiwan Ltd.
ID2
In Commercial Distribution

  • 04719894432007 ()


  • Pelvic-organ-supporting pessary
INCONTINENCE RING PESSARY, Inflatable Donut, ID2.00 #2
Bioteque America, Inc.
ID2
In Commercial Distribution

  • 00810142352017 ()


  • Pelvic-organ-supporting pessary
50` Neonatal Circuit, Temp port, Prox line, Drop line, Neo
WESTMED, INC.
N6205CKT
In Commercial Distribution

  • 10709078002943 ()
  • 00709078002946 ()


  • Anaesthesia breathing circuit, single-use
Dual Catheter Kit: 10'' Saturation catheter
Rex Pj Tech LLC
YK10
In Commercial Distribution

  • 10857362007317 ()
  • 00857362007310 ()


  • Prefilled mechanical infusion pump/catheter
Catheter Kit: 10'' Saturation catheter
Rex Pj Tech LLC
SK10
In Commercial Distribution

  • 10857362007300 ()
  • 00857362007303 ()


  • Prefilled mechanical infusion pump/catheter
Dual Catheter Kit: 5'' Saturation catheter with 6'' split sheath introducer
Rex Pj Tech LLC
YK8
In Commercial Distribution

  • 10857362007294 ()
  • 00857362007297 ()


  • Prefilled mechanical infusion pump/catheter
Catheter Kit: 5'' Saturation catheter with 6'' split sheath introducer
Rex Pj Tech LLC
SK8
In Commercial Distribution

  • 10857362007287 ()
  • 00857362007280 ()


  • Prefilled mechanical infusion pump/catheter
Dual Catheter Kit: 2.5'' Saturation catheter with 4'' split sheath introducer
Rex Pj Tech LLC
YK6
In Commercial Distribution

  • 10857362007270 ()
  • 00857362007273 ()


  • Prefilled mechanical infusion pump/catheter
Catheter Kit: 2.5'' Saturation catheter with 4'' split sheath introducer
Rex Pj Tech LLC
SK6
In Commercial Distribution

  • 10857362007263 ()
  • 00857362007266 ()


  • Prefilled mechanical infusion pump/catheter
Dual Catheter Kit: 5'' Saturation catheter with 4'' split sheath introducer
Rex Pj Tech LLC
YK5
In Commercial Distribution

  • 10857362007256 ()
  • 00857362007259 ()


  • Prefilled mechanical infusion pump/catheter
Catheter Kit: 5'' Saturation catheter with 4'' split sheath introducer
Rex Pj Tech LLC
SK5
In Commercial Distribution

  • 10857362007249 ()
  • 00857362007242 ()


  • Prefilled mechanical infusion pump/catheter
Dual Catheter Kit: Standard 3 hole catheter with 4'' split sheath introducer
Rex Pj Tech LLC
YK2
In Commercial Distribution

  • 10857362007232 ()
  • 00857362007235 ()


  • Prefilled mechanical infusion pump/catheter
Catheter Kit: Standard 3 hole catheter with 4'' split sheath introducer
Rex Pj Tech LLC
SK2
In Commercial Distribution

  • 10857362007225 ()
  • 00857362007228 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (250.0 ml/hr)
Rex Pj Tech LLC
BL1D250
In Commercial Distribution

  • 10857362007157 ()
  • 00857362007150 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (200.0 ml/hr)
Rex Pj Tech LLC
BL1D200
In Commercial Distribution

  • 10857362007140 ()
  • 00857362007143 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (100.0 ml/hr)
Rex Pj Tech LLC
BL1D100
In Commercial Distribution

  • 10857362007133 ()
  • 00857362007136 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (50.0 ml/hr)
Rex Pj Tech LLC
BL1D050
In Commercial Distribution

  • 10857362007126 ()
  • 00857362007129 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (10.0 ml/hr)
Rex Pj Tech LLC
BL1D010
In Commercial Distribution

  • 10857362007119 ()
  • 00857362007112 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (8.0 ml/hr)
Rex Pj Tech LLC
BL1D008
In Commercial Distribution

  • 10857362007089 ()
  • 00857362007082 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (5.0 ml/hr)
Rex Pj Tech LLC
BL1D005
In Commercial Distribution

  • 10857362007072 ()
  • 00857362007075 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (4.0 ml/hr)
Rex Pj Tech LLC
BL1D004
In Commercial Distribution

  • 10857362007065 ()
  • 00857362007068 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (2.0 ml/hr)
Rex Pj Tech LLC
BL1D002
In Commercial Distribution

  • 10857362007058 ()
  • 00857362007051 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (1.5 ml/hr)
Rex Pj Tech LLC
BL1D01/5
In Commercial Distribution

  • 10857362007041 ()
  • 00857362007044 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (0.8 ml/hr)
Rex Pj Tech LLC
BL1D00/8
In Commercial Distribution

  • 10857362007034 ()
  • 00857362007037 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Set (0.6 ml/hr)
Rex Pj Tech LLC
BL1D00/6
In Commercial Distribution

  • 10857362007027 ()
  • 00857362007020 ()


  • Prefilled mechanical infusion pump/catheter
Infuser – 275 mL Reservoir 275 mL Disposable Infusion Pump
Rex Pj Tech LLC
BL2N00
In Commercial Distribution

  • 00857362007013 ()
  • 10857362007010 ()


  • Prefilled mechanical infusion pump/catheter
Infuser – 110 mL Reservoir 100 ml Disposable Infusion Pump
Rex Pj Tech LLC
BL1N00
In Commercial Distribution

  • 00857362007006 ()
  • 10857362007003 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Kit S
STRADIS MEDICAL, LLC
100035
Not in Commercial Distribution

  • M7521000355 ()
  • M7521000351 ()


  • Prefilled mechanical infusion pump/catheter
Pump Supply Kit M
STRADIS MEDICAL, LLC
100018
Not in Commercial Distribution

  • M7521000181 ()
  • M7521000185 ()


  • Prefilled mechanical infusion pump/catheter
Infusion Kit O
STRADIS MEDICAL, LLC
100017
Not in Commercial Distribution

  • M7521000175 ()
  • M7521000171 ()


  • Prefilled mechanical infusion pump/catheter
Pump Supply Kit C
STRADIS MEDICAL, LLC
100016
Not in Commercial Distribution

  • M7521000161 ()
  • M7521000165 ()


  • Prefilled mechanical infusion pump/catheter
Add-On Bag Access Device Needle-Free Valve, Bag Access Port, Spike Adapter, Nonvented 93.5 cm (4 in)
BD Switzerland Sàrl
10013365
In Commercial Distribution

  • 37613203010420 ()
  • 07613203010412 ()
  • 27613203013912 ()

  • Length: 4 Inch
10013365

  • Negative-pressure intravenous line needleless valve-connector
with 0.8 micron filter
WESTMED, INC.
0520
In Commercial Distribution

  • 00709078001703 ()
  • 00709078002144 ()


  • Gas sampling line filter, single-use
Nexus NIS®-6P Luer Activated Injection Site
NEXUS MEDICAL, LLC
N6500
In Commercial Distribution

  • 30892855000745 ()
  • 10892855000741 ()


  • Neutral-pressure intravenous line needleless valve-connector
Nexus TKO®-6PHV Hi-Visibility Anti-Reflux Luer Activated Device
NEXUS MEDICAL, LLC
NX4650HV
In Commercial Distribution

  • 30892855000721 ()
  • 10892855000727 ()


  • Neutral-pressure intravenous line needleless valve-connector
Nexus TKO®-6P Anti-Reflux Luer Activated Device
NEXUS MEDICAL, LLC
NX4650
In Commercial Distribution

  • 30892855000509 ()
  • 10892855000505 ()
  • 50892855000503 ()


  • Neutral-pressure intravenous line needleless valve-connector
Nexus NIS®-6 Luer Activated Injection Site
NEXUS MEDICAL, LLC
N6000
In Commercial Distribution

  • 30892855000431 ()
  • 10892855000437 ()


  • Neutral-pressure intravenous line needleless valve-connector
Nexus TKO®-5 Anti-Reflux Split Septum Device
NEXUS MEDICAL, LLC
NX1500
In Commercial Distribution

  • 30892855000028 ()
  • 10892855000024 ()


  • Neutral-pressure intravenous line needleless valve-connector
Nexus TKO®-4S Anti-Reflux Luer Lock Device
NEXUS MEDICAL, LLC
NX1450
In Commercial Distribution

  • 30892855000011 ()
  • 10892855000017 ()


  • Neutral-pressure intravenous line needleless valve-connector
KEN_FLO NEEDLE FREE CONNECTOR
KENTRON HEALTHCARE, INC.
429000
In Commercial Distribution

  • 10852244007140 ()
  • 00852244007143 ()
429000

  • Positive-pressure intravenous line needleless valve-connector
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