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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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Bacterial: 99.998%, Viral: 99.96%, Adult/Ped : Tidal Volume Range(150-1500mL), Breathing Resistance(1.4cm H2O at 60 L/min), Dead Space(45mL), Weight(21g)
Dynarex Corporation
30400
In Commercial Distribution

  • 00840117305878 ()
  • 00840117305861 ()


  • Heat/moisture exchanger insertable filter
Adult, Tidal Volume Range(150-1500mL), Media(Foam), Dead Space(62 (34)mL), Breathing Resistance(3.0cm H2O at 60 L/min), Weight(24g), Adult
Dynarex Corporation
30204
In Commercial Distribution

  • 00840117305465 ()
  • 00840117305458 ()


  • Heat/moisture exchanger/microbial medical gas filter
Adult, Tidal Volume Range(250-1500mL), Media(Foam + Flat Media), Dead Space(89 (60)mL, Breathing Resistance(2.0cm H2O at 60L /min), Weight (45g)
Dynarex Corporation
30106
In Commercial Distribution

  • 00840117305366 ()
  • 00840117305359 ()


  • Heat/moisture exchanger/microbial medical gas filter
V. Mueller KNOLLE LENS NUCLEUS SPATULA and GAUGE, 30MM LG NARROW SPATULA BLD, MARKINGS AT 5, 6 AND 7MM FROM TIP, RND HNDL
STERIS CORPORATION
OP0920-991
In Commercial Distribution

  • 10885403095191 ()
OP0920991

  • Ophthalmic surgical probe, reusable
DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications.
DIAGNOSTIC GRIFOLS SA
213734
In Commercial Distribution

  • 08437014205169 ()
213734

  • Microplate/tube/assay card incubator IVD
Gimbel irrigating cannula, 30 gauge, straight, U-shaped tip for cortex removal at the 12 o'clock position, front opening, 28.0mm overall length excluding hub
AMBLER SURGICAL CORP.
Gimbel irrigating cannula
In Commercial Distribution

  • 00190660004279 ()
1419E

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Drews capsule polisher cannula, 25 gauge, angled, 2.5mm posterior sandblasted ring tip, 0.2mm irrigating port at 6 o'clock, 23.0mm overall length excluding hub
AMBLER SURGICAL CORP.
Drews capsule polisher cannula
In Commercial Distribution

  • 00190660003814 ()
1135E

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
The AS3D tip is intended for apical surgery of anterior teeth. It should be used without pressure, at the lowest possible effective power.
SATELEC
TIP AS3D
In Commercial Distribution

  • 03609820000657 ()
F00065

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
CIN Agar, 15x100 monoplate, 10/pk (Cefsulodin, Irgasan, Novobiocin) For the selective isolation of Yersinia enterocolitica and Aeromonas spp. Inoculate at room temperature.
HARDY DIAGNOSTICS
G220
Not in Commercial Distribution

  • 00816576025404 ()
  • 00816576025411 ()
G220

  • Differential/selective agar culture medium IVD
Henderson Style Pre-Op Reference Marker, Half Circle With 3 Blunt Alignment Pins At 0, 90 and 180 Degrees, with Round Knurled Handle, Titanium
Surgical Direct, Inc.
S34016.200T
In Commercial Distribution

  • B382S34016200T0 ()
S34016.200T

  • Intraocular retractor, reusable
Dialysate Additive 9.8 grams Potassium Chloride increases Potassium by 1.0 mEq/L when added to 3.785 liters of concentrate proportioned at 1:34
DIASOL, INC.
PC9.8
In Commercial Distribution

  • B467PC98145 ()
  • B467PC98 ()

  • Weight: 9.8 Gram
PC19

  • Haemodialysis concentrate
Dialysate Additive 6.3 grams Potassium Chloride increases Potassium by 0.5 mEq/L when added to 3.785 liters of concentrate proportioned at 1:44
DIASOL, INC.
PC6.3
In Commercial Distribution

  • B467PC63170 ()
  • B467PC63 ()

  • Weight: 6.3 Gram
PC18

  • Haemodialysis concentrate
Dialysate Additive 5.8 grams Potassium Chloride increases Potassium by 0.5 mEq/L when added to 3.43 liters of concentrate proportioned at 1:44
DIASOL, INC.
PC5.8
In Commercial Distribution

  • B467PC58170 ()
  • B467PC58 ()

  • Weight: 5.8 Gram
PC17

  • Haemodialysis concentrate
Dialysate Additive 15.9 grams Potassium Chloride increases Potassium by 0.5 mEq/L when added to 9.46 liters of concentrate proportioned at 1:44
DIASOL, INC.
PC15.9
In Commercial Distribution

  • B467PC159145 ()
  • B467PC159 ()

  • Weight: 15.9 Gram
PC16

  • Haemodialysis concentrate
Dialysate Additive 12.7 grams Potassium Chloride increases Potassium by 1.0 mEq/L when added to 3.785 liters of concentrate proportioned at 1:44
DIASOL, INC.
PC12.7
In Commercial Distribution

  • B467PC127120 ()
  • B467PC127 ()

  • Weight: 12.7 Gram
PC15

  • Haemodialysis concentrate
Dialysate Additive 11.5 grams Potassium Chloride increases Potassium by 1.0 mEq/L when added to 3.43 liters of concentrate proportioned at 1:44
DIASOL, INC.
PC11.5
In Commercial Distribution

  • B467PC115145 ()
  • B467PC115 ()

  • Weight: 11.5 Gram
PC13

  • Haemodialysis concentrate
Dialysate Additive 8.6 grams Magnesium Chloride increases Magnesium by 0.5 mEq/L when added to 3.785 liters of concentrate proportioned at 1:44
DIASOL, INC.
MGC8.6
In Commercial Distribution

  • B467MG86 ()
  • B467MG86140 ()

  • Weight: 8.6 Gram
MGC22

  • Haemodialysis concentrate
Dialysate Additive 9.7 grams Calcium Chloride to increase Calcium by 1.0mEq/L when added to 3.785 liters of concentrate proportioned at 1:34
DIASOL, INC.
CC9.7
In Commercial Distribution

  • B467CC97145 ()
  • B467CC97 ()

  • Weight: 9.7 Gram
CC6

  • Haemodialysis concentrate
Dialysate Additive 6.3 grams Calcium Chloride to increase Calcium by 0.5mEq/L when added to 3.785 liters of concentrate proportioned at 1:44
DIASOL, INC.
CC6.3
In Commercial Distribution

  • B467CC63170 ()
  • B467CC63 ()

  • Weight: 6.3 Gram
CC4

  • Haemodialysis concentrate
Dialysate Additive 5.7 grams Calcium Chloride increases Calcium by 0.5 mEq/L when added to 3.43 liters of concentrate proportioned at 1:44
DIASOL, INC.
CC5.7
In Commercial Distribution

  • B467CC57170 ()
  • B467CC57 ()

  • Weight: 5.7 Gram
CC3

  • Haemodialysis concentrate
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