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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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The Instrumentation Industries, Inc. RTC 21-D Metered Dose Inhaler Adapter is intended for use in intermittent aerosol therapy to deliver aerosol medications (in compressed canister MDIs) via the proximal end of an endotracheal tube. The RTC 21-D MDI Adapter is intended for single patient use. This device is intended for sale by or on the order of a physician.
INSTRUMENTATION INDUSTRIES, INCORPORATED
RTC 21-D
In Commercial Distribution

  • M996RTC21D5 ()
  • M996RTC21D0 ()


  • Metered dose inhaler
The Instrumentation Industries, Inc. RTC 15-P is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 15-P Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. For use with metered dose inhaler canisters with standard size metal or plastic stems. The RTC 15-P Adapter is intended for Single Patient Reuse. This device is intended for sale by or on the order of a physician.
INSTRUMENTATION INDUSTRIES, INCORPORATED
RTC 15-P
In Commercial Distribution

  • M996RTC15P5 ()
  • M996RTC15P0 ()
RTC 15-P

  • Metered dose inhaler
The Instrumentation Industries, Inc. RTC 15-D is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 15-D Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. For use with metered dose inhaler canisters with standard size metal or plastic stems. The RTC 15-D Adapter is intended for Single Patient Reuse. This device is intended for sale by or on the order of a physician.
INSTRUMENTATION INDUSTRIES, INCORPORATED
RTC 15-D
In Commercial Distribution

  • M996RTC15D0 ()
  • M996RTC15D5 ()
RTC 15-D

  • Metered dose inhaler
This adapter connects to the exhalation valve for additional versatility.
INSTRUMENTATION INDUSTRIES, INCORPORATED
PS 54-1A
In Commercial Distribution

  • M996PS541A0 ()
  • M996PS541A2 ()


  • Non-rebreathing valve, reusable
NP 1000-2D Bag Hanger mates with arm of O2 Instant Flow Valve to support a resuscitation bag. This is an accessory to the BE 3000 Series Oxygen Instant Flow Valves. Single Patient Use
INSTRUMENTATION INDUSTRIES, INCORPORATED
NP 1000-2D
In Commercial Distribution

  • M996NP10002D5 ()
  • M996NP10002D0 ()
NP 1000-2D

  • Respiratory oxygen therapy system
NL 100 Breast Marker is used to assist in nipple placement during breast reconstructive surgery. A temporary impression is made by pressing the marker onto skin with a gentle rotating motion. Methylene blue may be used as a marking agent. The NL 100 Breast Marker provides two marking edges: 42 mm and 38 mm.
INSTRUMENTATION INDUSTRIES, INCORPORATED
NL 100
In Commercial Distribution

  • M996NL1004 ()
  • M996NL1000 ()
NL 100

  • Skin marking guide, single-use
The KM 030 Disposable Connector with LCD Thermometer is intended for use in a ventilator circuit, or a heated aerosol circuit. The LCD thermometer gives approximate temperature readings only and is not a substitute for definitive temperature monitoring. Dimensions: 22mm O.D. x 22mm I.D. Single Patient Use. Molded of High Density Polyethylene.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KM 030
In Commercial Distribution

  • M996KM0305 ()
  • M996KM0300 ()
KM 030

  • Straight/elbow breathing circuit connector, single-use
The KC 9-P with removable cap is designed for use on ventilators not equipped with expiratory hold. It allows single breath measurement of auto-PEEP in its use as a Braschi valve. Objectives of PEEP therapy: 1) increase functional residual capacity by maintaining a positive pressure throughout the ventilatory cycle - improves gas distribution, 2) aid in the prevention of atelectasis via aveolar stinting, 3) decrease in the inspired oxygen fraction (FiO2) is an advantage, 4) help in the stabilization of flail chest condition, and 5) monitor tidal volume by connecting a spirometer to the outlet port.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 9-P
In Commercial Distribution

  • M996KC9P0 ()
  • M996KC9P2 ()


  • Non-rebreathing valve, single-use
90 degree Elbow Connector - 15mm ID/22mm OD x15mm OD. Molded of polystyrene butadiene. Single patient use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 18901-K
In Commercial Distribution

  • M996KC18901K5 ()
  • M996KC18901K0 ()
KC 18901-K

  • Straight/elbow breathing circuit connector, single-use
Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel), porcelain, zirconia, composite restorations, acrylic temporary/pontic teeth. This is a Unidose dispensing system. Single unidose capsule
RELIANCE ORTHODONTIC PRODUCTS INC
UAPSAM
In Commercial Distribution

  • D798UAPSAM1 ()
  • D798UAPSAM0 ()
UAPSAM

  • Dentine bonding agent/set
Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel), porcelain, zirconia, composite restorations, acrylic temporary/pontic teeth. This is a Unidose dispensing system.
RELIANCE ORTHODONTIC PRODUCTS INC
UAP50
Not in Commercial Distribution

  • D798UAP501 ()
  • D798UAP500 ()
  • D798UAP502 ()
UAP50

  • Dentine bonding agent/set
Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. Rely•a•Bond® is a No Mix Bonding System that sets on contact. This is the Rely A Bond 14g Adhesive paste in Tips.
RELIANCE ORTHODONTIC PRODUCTS INC
RPT
In Commercial Distribution

  • D798RPT1 ()
  • D798RPT0 ()
  • D798RPT2 ()
RPT

  • Orthodontic bracket adhesive
Suction Connection Tubing, 2 meters, 1/4 inch internal diameter, Sterile
ENDURE INDUSTRIES
STS162021217
In Commercial Distribution

  • B531STS162020 ()
  • B531STS162022 ()

  • Lumen/Inner Diameter: .25 Inch
  • Length: 2 Meter
STS16202

  • Suction/irrigation tubing, single-use
Oxygen Mask and Tubing, Size Extra Large, Non-Sterile
ENDURE INDUSTRIES
OMTX21217
In Commercial Distribution

  • B531OMTX22 ()
  • B531OMTX20 ()

  • Mask Size XL
OMTX2

  • Rebreathing oxygen face mask
Oxygen Mask and Tubing, Size Large, Non-Sterile
ENDURE INDUSTRIES
OMTL21017
In Commercial Distribution

  • OMTL22 ()
  • B531OMTL20 ()

  • Mask Size L
OMTL2

  • Rebreathing oxygen face mask
Nasal Oxygen Cannula, Size Extra Large, Length 4 Meters
ENDURE INDUSTRIES
NCX421217
In Commercial Distribution

  • B531NCX422 ()
  • B531NCX420 ()

  • Length: 4 Meter
NCX42

  • Nasal oxygen cannula, basic
Nasal Oxygen Cannula, Size Extra Large, Length 2 Meters
ENDURE INDUSTRIES
NCX221217
In Commercial Distribution

  • B531NCX222 ()
  • B531NCX220 ()

  • Length: 2 Meter
NCX22

  • Nasal oxygen cannula, basic
Nasal Oxygen Cannula, Size Large, Length 4 Meters
ENDURE INDUSTRIES
NCL421217
In Commercial Distribution

  • B531NCL422 ()
  • B531NCL420 ()

  • Length: 4 Meter
NCL42

  • Nasal oxygen cannula, basic
Nasal Oxygen Cannula, Size Large, Length 2 meters
ENDURE INDUSTRIES
NCL221217
In Commercial Distribution

  • B531NCL222 ()
  • B531NCL220 ()

  • Length: 2 Meter
NCL22

  • Nasal oxygen cannula, basic
NPWT Ported Dome pad
LC MEDICAL CONCEPTS
UTD24
In Commercial Distribution

  • B530UTD241 ()
  • B530UTD250 ()
UTD24

  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
Ultraviolet tanning device
BLV Licht- und Vakuumtechnik GmbH
HPA 700/800 FX C
Not in Commercial Distribution

  • B5331191500 ()
  • B533119151 ()
119150

  • Ultraviolet tanning device
No Description
BLV Licht- und Vakuumtechnik GmbH
M 400W R7s
Not in Commercial Distribution

  • B5331181261 ()
  • B5331181260 ()
  • B5331036990 ()
118126

  • Ultraviolet tanning device
No Description
BLV Licht- und Vakuumtechnik GmbH
Q-04500SI
Not in Commercial Distribution

  • B5331181231 ()
  • B5331181230 ()
  • B5331037010 ()
118123

  • Ultraviolet tanning device
No Description
BLV Licht- und Vakuumtechnik GmbH
HP 400-500W R7s
In Commercial Distribution

  • B5331181221 ()
  • B5331181220 ()
  • B5331037000 ()
118122

  • Ultraviolet tanning device
No Description
BLV Licht- und Vakuumtechnik GmbH
M 500 R7s
Not in Commercial Distribution

  • B5331181191 ()
  • B5331181190 ()
  • B5331035980 ()
118119

  • Ultraviolet tanning device
No Description
BLV Licht- und Vakuumtechnik GmbH
HPA 700 S FX
Not in Commercial Distribution

  • B5331181141 ()
  • B5331181140 ()
  • B5331039340 ()
118114

  • Ultraviolet tanning device
No Description
BLV Licht- und Vakuumtechnik GmbH
HPA 400 S
Not in Commercial Distribution

  • B5331181061 ()
  • B5331181060 ()
118106

  • Ultraviolet tanning device
No Description
BLV Licht- und Vakuumtechnik GmbH
HPA 400/30 S L
In Commercial Distribution

  • B5331181001 ()
  • B5331181000 ()
  • B5331039010 ()
118100

  • Ultraviolet tanning device
No Description
BLV Licht- und Vakuumtechnik GmbH
LET 004.0004
Not in Commercial Distribution

  • B5331180732 ()
  • B5331180730 ()
  • B5331170260 ()
118073

  • Ultraviolet tanning device
No Description
BLV Licht- und Vakuumtechnik GmbH
HPA 400/30 SD L
Not in Commercial Distribution

  • B5331180561 ()
  • B5331180560 ()
  • B5331039130 ()
118056

  • Ultraviolet tanning device
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